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ZIMMER GMBH WAGNER CONE PROSTHESIS, 135, UNCEMENTED 14, TAPER 12/14; WAGNER CONE PROSTHESIS 135 SIZE 14
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| Model Number N/A |
| Device Problems
Fracture (1260); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Pain (1994); No Information (3190)
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| Event Date 11/15/2018 |
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical product: protasul, s30 head, m¸ 28/0, taper 12/14; catalog no#: 30.28.06; lot#: 2576771; bone screw self-tapping 6.5 mm dia.25 mm length; catalog no#: 00-6250-065-25 ; lot#: 61547349; shell porous with cluster holes 48 mm o.D.; catalog no#: 00-6200-048-22 ; lot#: 61536417.Therapy date: (b)(6) 2018.The manufacturer received document for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the explanted devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Patient was implanted on the unknown side and underwent revision surgery due to broken implant.
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Event Description
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Patient was implanted on the left side and underwent revision surgery due to broken implant and pain.
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Manufacturer Narrative
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Additional information which was received on jun 25, 2019.The manufacturer received x-rays, other source documents (surgical reports, photos) for review.Since this case is related to the issues for which zimmer implemented a corrective action which was reported to the fda in july 2008 as correction z-2415/2426-2008, there will be no further investigation and zimmer gmbh will close this case once again.Zimmer¿s reference number of this file is (b)(4).
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Manufacturer Narrative
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This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: fracture event description: it was reported that the patient was implanted with the wagner cone and protasul head on (b)(6) 2011 and underwent revision on (b)(6) 2018 due to fracture of wagner cone hip stem (approx.4 cm from the distal end of the stem).Review of received data: implant stickers of the following components have been received: ref:01.00561.314, lot: 2548662 - wagner cone prosthesis, ref: 30.28.06, lot: 2576771 - protasul s-30 head 28 mm, - ref: 00-6110-048-28, lot: 61521032 - trilogy acetabular liner, - ref: 00-6200-048-22, lot: 61536417 - trilogy acetabular shell, - ref: 6250-65-40, lot: illegible - bone screw, - ref: 6250-65-25, lot: 61547349 - bone screw, - ref: 6200-48-22, lot: 61536417 - bone screw.- in total 6 intraoperative photographs have been received for review.On one image the retrieved proximal stem part with the protasul s-30 head is depicted, on a second image also the broken off distal stem part is shown.On both images some tissue and blood residues can be seen.The stem fracture occurred approx.4 cm from the stem's distal tip.The other 4 images show manipulation at the medullary canal.- in total 5 x-rays have been received for review.Two x-rays were taken pre and three x-rays were taken post revision surgery.The following x-ray analysis has been performed by a health care professional (hcp).Pelvis overview taken before revision shows a cup inclination angle of approx.47°.The stem is broken in the most distal third with varus tilting of the proximal part by approx.7°.The left hip tilted ap-view shows the broken stem and an insufficient support of the stem by the medullary cavity.Conclusion: comparable radiological examinations after primary implantation are not available.The only usable x-ray documentation shows the situation with broken stem.Here, the stem used appears undersized in its proximal and distal third in relation to the medullary cavity.Additional information from the primary implant surgery report is not available.Why it has come to the expansion of the medullary cavity, cannot be found in the available documents.Are known at the time of primary implantation, a patient age of 59 years and a male gender.At the time of the event description a significant overweight with bmi of 44.6.What has ultimately led to the failure of the femoral component, can only be assumed.When selecting the size of the wagner cone stem prosthesis it is important that the configuration of the femur allows close contact between the middle third of the prosthetic stem and the cortex, and not just that the tip of the stem fits tightly in the medullary cavity.Medical history: in childhood, patient was diagnosed with bilateral dysplastic coxarthrosis, however, no surgery was performed.Since 1994, the pain in both tbs intensified.Over time, lameness appeared, limitation of movements and pain progressed.The patient began to move with a cane.In 2010 and 2011, the tec of the right and left tbs was treated in rniito named after r.R.Vreden.The postoperative period was uneventful.Moved with a cane.In the last year, a sudden pain syndrome appeared in the area of the left hip joint during physical exertion.The control radiographs revealed a fracture of the femoral component of the endoprosthesis.Patient details: male patient, 149 cm tall, 99 kg.The patient was 59 years old at time of implantation.Surgical report of revision surgery performed on (b)(6) 2018.Operation: revision endoprosthetics of the left hip joint, operation time: 2 hours, blood loss: 0.4 l.The old scar was incised and access was gained.The muscles in the greater trochanter were degenerative altered.No fluid was released from the joint cavity, but scarred tissue was found.5 tissue biopsies were taken and sent for microbiological examination.The endoprosthesis was dislocated and unstable.The acetabular component was stable.Uneventful removal and insertion of a new liner.The proximal fragment of the femoral component was removed.The distal end of the femoral component was broken and tightly fixed in the channel.Using a revision toolkit, the distal component could be retrieved by opening a window in the femur at the lower edge of the fractured femoral fragment.The femoral canal was rasped and a wagner revision stem 14/190 was inserted.Device analysis: - visual examination: the fractured wagner stem with mounted head has been received for investigation.The stem fracture is located 4 cm from the stem's distal tip.The broken off distal component has a lot of bone attachments on the intact surfaces.However, two-thirds of the surfaces are completely destroyed.The flanks have been removed and the surface is full of indentations and deformations.The fracture surface on the distal component but also the fracture surface on the proximal component is highly polished making a fracture surface analysis impossible.The proximal component does not show any bone attachments, but marks from an electrocautery device can be found on the stem's neck.All surfaces are still intact, however, some scratches can be seen on the neck and close to the neck.Scratches can also be seen on the head's surface.Based on this visual examination the reported event can be confirmed.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Inspection plan sap: characteristic no.02 feature multiple dimensions with scope of testing: 100%.Means of inspection: 3d measuring machine, characteristic no.04 feature stem length with scope of testing: 100%.Means of inspection: caliper - characteristic no.05 feature flank width with scope of testing: 100%.Means of inspection: measuring magnifier - characteristic no.07 feature surface inspection aau q.42.000 with scope of testing: 100%.Means of inspection: visual - surgical technique: preoperative planning: when selecting the size of the wagner cone prosthesis stem it is important that the configuration of the femur allows close contact between the middle third of the prosthetic stem and the cortex, and not just that the tip of the stem fits tightly in the medullary cavity.Selection of the correct stem diameter is particularly important.The most common mistake consists in choosing a stem diameter that is too thin.In choosing the diameter, it must be remembered that reaming with the reamer removes a thin layer of bone and that the sharp longitudinal ribs cut slightly into the bone during insertion.The outline of the prosthetic stem on the planning template must therefore overlap the inner outline of the cortex in the region of the middle third of the stem by 1 mm on each side.- instruction for use (ifu) femoral stems for total hip arthroplasty states, amongst many others, the following statements: contraindications: patient¿s physical conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, e.G.Previous surgery, insufficient quality or quantity of bone resulting from conditions such as cancer or congenital dislocation, metabolic bone disease of the upper femur or pelvis, femoral osteotomy revision, girdlestone revision, osteoporosis, osteomyelitis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable (e.G.Absence of musculoligamentous supporting structures, joint neuropathy) or other conditions that may lead to inadequate skeletal fixation.Warnings: do not use any component if damage is found or caused during setup or insertion.Complications or failure of any total hip prosthesis are more likely to occur in heavy patients.The smaller size stems in the heavy or physically-active individual are particularly at risk.A younger patient tends to be more active and to gain weight.In addition, if the individual has other medical disabilities that create or result in an unusual gait, stresses on the femoral component may be exacerbated.The smaller sized femoral stems are designed for patients with a small intramedullary canal and/or metaphyseal region of the femur.The stem cross-sectional geometry has been decreased to accommodate this special anatomical requirement.This reduction in size results in a corresponding reduction in the fatigue strength of the implant.Because of this, the prospective patient should be screened carefully.These smaller femoral stems are suitable only for a patient who has a low-to-moderate activity level.Patients who are young, heavy and those who engage in high physical activity levels are not suitable candidates for the smaller sized femoral prostheses.The load-bearing capacity of the implant can be compromised by notching, scratching, or striking the prosthesis, repeated assembly/disassembly of the modular components, or failing to provide metaphyseal support to the implant.Improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions reducing the service life of the prosthetic implants.Avoid varus stem placement.Varus stem placement results in higher stresses on the stem, increasing the risk of fatigue fracture of the stem.Adverse effects: fatigue fractures patient counseling information: complications and/or failure of prosthetic implants are more likely to occur in patients with unrealistic functional expectations, heavy patients, physically active patients and/or with patients who fail to follow through with the required rehabilitation program.Physical activity can result in loosening, wear and/or fracture of the implant.The patient must be instructed about all postoperative restrictions, particularly those related to occupational and sports activities and about the possibility that the implant or its components may wear out, fail or need to be replaced.Conclusion: in a 59-year old patient a wagner cone stem with protasul head on the left side was implanted on (b)(6) 2011.After uneventful postoperative period a sudden pain syndrome appeared in the area of the left hip joint during physical exertion in 2018.A radiologically recognizable breakage of the femoral component was identified.Due to the stem fracture a revision took place on (b)(6) 2018.The patient had a bilateral dysplastic coxarthrosis since childhood and was 59 years old at time of implantation.The male patient is obese with 149 cm in height and 99 kg of body weight.The x-ray review revealed a cup inclination angle of around 47°.Radiologically the stem fracture is visible in the most distal third part of the stem.The proximal part of the stem is depicted in a varus tilted position by approx.7°, which correlates with the surgical report of the revision surgery which states that the endoprosthesis was dislocated and unstable.Further, except of the distal part of the stem, the stem is not supported by the medullar cavity, contradictory to the applicable surgical technique, which states that the middle third of the stem must have a tight fit within the medullary cavity.In addition, according to the surgical technique special care must be taken in obese patients, as the likelihood of device fracture in heavy patients is more likely.Based on the x-ray review, the patient history and review of the surgical technique it is possible that the lack of stability, possibly due to use of an undersized stem, in combination with the overweight of the patient has contributed to material fatigue and ultimately to the breakage of the stem.Nevertheless, as no x-rays are available which show the postoperative situation after implantation, a change in position and osseointegration could not be evaluated.The visual examination confirmed the stem fracture approx.4 cm from the stem's distal tip.The broken off distal part shows a high amount of bone attachments on intact surfaces, otherwise no bone attachments were found, which correlates with the findings of the x-ray analysis.Further, most of the distal surface structure was completely destroyed during removal of the component.The fracture surfaces are completely polished, therefore, fracture surface analysis could not be performed.The high degree of polishing of the fracture surfaces indicates that the stem has been in-situ for a long time after the fracture.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).In conclusion, based on the x-rays the wagner stem is lacking the necessary support of the medullary canal around the central part of the stem.In addition, the patient's weight may have negatively influenced the performance of the device.Therefore, the most likely root cause for the device fracture is the lack of bony support in combination with the patient's weight.As the postoperative x-rays after implantation are missing, a root cause for the missing medullary support could not be evaluated.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Please refer to report 0009613350 - 2018 - 01251.
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Event Description
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The investigation results have been updated.
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Manufacturer Narrative
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Investigation results have been updated.Dhr-review: ref: (b)(4).Lot: 2548662 (wagner cone stem) yield: 17 delivered: 16 scrapped: 1 reason for scrapping: 1 part scrapped in pre-processing step the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: fracture event description: a wagner cone prosthesis was implanted on the left side in a 59-year old patient on (b)(6) 2011.The stem was combined with a protasul s30 head, a trilogy cluster hole cup fixated with 2 screws and a trilogy liner.After uneventful postoperative course sudden pain appeared in the area of the left hip joint during physical exertion in 2018.A radiographic control showed a fracture of the femoral stem.Due to the stem fracture a revision took place on (b)(6) 2018.Review of received data: implant stickers of the following components have been received: ref: (b)(4).Lot: 2548662 - wagner cone prosthesis, ref: (b)(4).Lot: 2576771 - protasul s-30 head 28 mm, ref: (b)(4).Lot: 61521032 - trilogy acetabular liner, ref: (b)(4).Lot: 61536417 - trilogy acetabular shell, ref: (b)(4).Lot: illegible - bone screw , ref: (b)(4).Lot: 61547349 - bone screw, ref: (b)(4).Lot: 61536417 - bone screw.In total five x-rays, three x-rays taken pre-revision and two x-rays taken post-revision, have been received for review.Post-revision x-rays were excluded from this investigation.The following x-ray analysis was performed by a health care professional.Based on the pelvis overview (x-ray 1) a cup inclination angle of approx.47° was assessed.A stem fracture inf the distal third part of the stem and an insufficient support of the proximal stem due to a widened medullary canal is visible in all three x-rays (x-ray 1 thru x-ray 3).The proximal fracture part of the stem is in varus tilted position (of approx.7°) when compared to the stem axis of the distal fracture part (x-ray 2).The distal fracture part appears firmly seated (x-ray 1 thru x-ray 3).The x-ray follow-up of the primary implantation is not available.- medical history: as stated in the product medical history the patient was diagnosed with bilateral dysplastic coxarthrosis in childhood, however, no surgery was performed.Further, it was reported that the pain in both "tbs" intensified since 1994.Over time lameness appeared as well as limitation of movement and increase in pain.The patient started walking with a cane.In 2010 and 2011, the "tec" of the right and the left "tbs" were treated in the clinic rniito (named after r.R.Vreden).The postoperative course was described as uneventful.In the last year, the patient felt sudden pain in the area of the left hip joint during physical exertion.The radiographic control revealed a fracture of the femoral stem.Patient details: male patient, 149 cm tall, 99 kg.The patient was 59 years old at time of implantation.Revision report, (b)(6) 2018: operation: revision endoprosthesis of the left hip procedure (summary): the old scar was incised and access was gained.The muscles in the greater trochanter were degenerative altered.No fluid drained from the joint cavity when opening, but scarred tissue was found.The stem was found to be dislocated and unstable.The acetabular component was stable - uneventful removal of the liner and insertion of a new liner.The proximal fracture part of the femoral stem was removed.The distal fracture part of the stem was tightly fixed in the medullary canal.Using a revision toolkit, the distal fracture part could be retrieved by a femoral window.The medullary canal was rasped and a wagner revision stem 14/190 was inserted.Devices analysis: - visual examination: the fractured wagner cone prosthesis with mounted protasul s30 head has been received for investigation.No additional parts were received.The stem fracture is located approx.4 cm above the stem's distal tip (picture 1 and picture 2).Approx.Half of the distal fracture part¿s anchorage surface is deformed or completely destroyed.Bone attachments can be found on the intact surface of the distal fracture part (picture 3 and picture 4).On the proximal fracture part, no bone attachments can be found.Further, sings of loosening and marks from an electrocautery tool can be found in the neck region of the stem.On the head's surface, patches of scratches can be found (picture 5 and picture 6).Both fracture surfaces are completely worn and highly polished, making a fracture surface analysis impossible (picture 7 and picture 8).Based on this visual examination the reported event can be confirmed.Review of product documentation: - all involved devices are intended for treatment.- the compatibility check was performed and showed that the product combination was approved by zimmer biomet.- inspection plan sap doc no.55209 rev.06: - characteristic no.02 feature multiple dimensions with scope of testing: 100%.Means of inspection: 3d measuring machine - characteristic no.04 feature stem length with scope of testing: 100%.Means of inspection: caliper - characteristic no.05 feature flank width with scope of testing: 100%.Means of inspection: measuring magnifier - characteristic no.07 feature surface inspection aau q.42.000 with scope of testing: 100%.Means of inspection: visual - surgical technique: preoperative planning: when selecting the size of the wagner cone prosthesis stem it is important that the configuration of the femur allows close contact between the middle third of the prosthetic stem and the cortex, and not just that the tip of the stem fits tightly in the medullary cavity.Selection of the correct stem diameter is particularly important.The most common mistake consists in choosing a stem diameter that is too thin.In choosing the diameter, it must be remembered that reaming with the reamer removes a thin layer of bone and that the sharp longitudinal ribs cut slightly into the bone during insertion.The outline of the prosthetic stem on the planning template must therefore overlap the inner outline of the cortex in the region of the middle third of the stem by 1 mm on each side.- instruction for use (ifu) femoral stems for total hip arthroplasty: the following summary covers the warnings most relevant to the current complaint stated in the instructions for use of the wagner cone prosthesis valid at the time of production: warnings: - complications or failure of any total hip prosthesis are more likely to occur in heavy patients.- the smaller size stems in the heavy or physically-active individual are particularly at risk.A younger patient tends to be more active and to gain weight.- the smaller sized femoral stems are designed for patients with a small intramedullary canal and/or metaphyseal region of the femur.The stem cross-sectional geometry has been decreased to accommodate this special anatomical requirement.This reduction in size results in a corresponding reduction in the fatigue strength of the implant.Patients who are young, heavy and those who engage in high physical activity levels are not suitable candidates for the smaller sized femoral prostheses.- the load-bearing capacity of the implant can be compromised by or failing to provide metaphyseal support to the implant.Fatigue fracture is a possible adverse effect and stated as such in the ifu.Conclusion summary: a wagner cone prosthesis was implanted on the left side on (b)(6) 2011.After uneventful postoperative course sudden pain appeared in the left hip joint during physical exertion in 2018.A radiographic control revealed a fracture of the femoral stem.Due to the stem fracture a revision took place on (b)(6) 2018.The review of the quality records of the wagner cone prosthesis and the protasul s30 head show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.According to the patient history, the male patient had a bilateral dysplastic coxarthrosis since childhood.Based on the reported data, the patient is 149 cm in height and 99 kg of body weight, which correlates to a body mass index (bmi) of 44.6, which is considered obese.The visual examination confirmed the stem fracture approx.4 cm from the stem's distal tip.Approx.Half of the distal fracture part¿s anchorage surface was destroyed during removal of the component.On the intact anchoring surface, bone attachments are seen.No bone attachments but signs of loosening in the neck can be found on the proximal fracture part.The type of fracture could not be determined due to the high degree of wear and polishing on the fracture surfaces which could indicates that the stem stayed in-situ for a longer time after the fracture.The x-ray review of the pre-revision x-rays showed the stem fracture in the distal third part of the stem.Further, the proximal fracture part is lacking support by the medullary cavity, while the distal fracture part seems to be firmly fixed.This correlates with the findings of the visual examination and may indicate partial loosening and possible insufficient metaphyseal support of the proximal area of the stem.As the x-ray follow-up of the primary implantation is missing, the initial situation and a potential change over the time in vivo could not be evaluated.Review of the applicable ifu shows that this stem size could be at risk of fatigue fracture in young, heavy, physically-active patients or in case of insufficient metaphyseal support of the implant.Therefore, it is assumed that the cause for the stem fracture is multifactorial including patient as well as surgical factors.Potential factors, amongst others, include patient weight, patient activity level, patient comorbidities, stem size, possible insufficient support of the medullary canal to the proximal region of the implant and possible partial stem loosening.If and to what extent these potential factors have contributed to the stem fracture cannot be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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