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| Model Number N/A |
| Device Problem
Fracture (1260)
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| Patient Problem
Pain (1994)
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| Event Date 12/29/2017 |
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Event Type
Injury
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Manufacturer Narrative
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The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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).Product reference unknown.
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Event Description
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It was reported that patient underwent revision surgery due to pain.During the revision surgery it was noticed that the implanted head was broken into at least five pieces.
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Manufacturer Narrative
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Concomitant medical products according : fitmore, hip stem, uncemented, 6, taper 12/14 , ref#: unknown, lot#: unknown.Unknown allofit shell 54mm, ref#: unknown , lot#: unknown.Nknown inlay, ref#: unknown , lot#: unknown.As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer gmbh winterthur legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer gmbh never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer gmbh as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.A technical investigation was not possible to be performed, as the devices were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Dhr review: as no lot number was provided, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: analysis could not be performed as no item numbers are available.Event description: it was reported that a female patient had an implantation of a total endoprosthesis of the left hip on (b)(6) 2016 (cementless).On (b)(6) 2017 the patient sat on the couch with stretched out legs and in a relaxing position.Her neck was supported by a pillow.Suddenly the patient heard a loud noise.As the patient tried to stand up there was an instant pain in the area of the left hip.The patient went to hospital but there couldn't be found out what the origin of the pain was.It just was given analgesics and it was said that the patient should await the following weekend (with the turn of the year).But the pain wasn't getting better and so the patient went to hospital on (b)(6) 2017 again.She underwent a revision surgery on (b)(6) 2018.Review of received data: primary surgery report is reviewed.No operative details were available.Attorney letter is reviewed.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: compatibility check could not be performed as no ref numbers of components except the stem was available.Surgical technique was not reviewed as the surgical report was not containing the operation steps.Conclusion summary: patient underwent revision surgery due to ceramic head fracture after approx.2 years in-vivo time.The investigation results did not identify a non-conformance or a complaint out of box (coob).Dhr review could not be done since the lot number was not reported.Based on the given information the complaint could not be confirmed and no specific root cause could be determined for this issue.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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Investigation results have been made available.
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Event Description
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No change to previously reported event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay updated and additional information.Event summary: it was reported that a female patient had an implantation of a total endoprosthesis of the left hip on (b)(6) 2016 (cementless).On (b)(6) 2017 the patient sat on the couch with stretched out legs and in a relaxing position.Her neck was supported by a pillow.Suddenly the patient heard a loud noise.As the patient tried to stand up there was an instant pain in the area of the left hip.The patient went to hospital but there couldn't be found out what the origin of the pain was.It just was given analgesics and it was said that the patient should await the following weekend (with the turn of the year).But the pain wasn't getting better and so the patient went to hospital on (b)(6) 2017 again.She underwent a revision surgery on (b)(6) 2018.Review of received data no further due diligence required as all required information to support the conclusion is available/was already requested.Primary surgery report dated (b)(6) 2016 is reviewed.No operative details were available.Attorney letter dated 04 mar 2019 is reviewed.Additional documents received on 04 may 2020: doctor letter dated 23 jan 2015: diagnosis: coxarthrosis on both sides, left more significant.Doctor letter dated 26 jan 2015: medium degree of coxarthrosis left and right hip joint radiological report dated (b)(6) 2016: pelvic overview from (b)(6) 2016: progressed coxarthrosis, left more than right hip joint.Radiological report dated (b)(6) 2016: pelvic overview from (b)(6) 2016: hip prosthesis with short stem, good articulation and good cup inclination angle of approx.42 degree.No material fracture, no periprosthetic fracture.Pictures of explants: six pictures showing the 5 large fragments were received, however, the quality is low.There is metal transfer visible on all fragments, at the taper area as well as the fracture surface.Moreover, one picture shows the outer surface explanted allofit cup, which has some presumably bone attachment on it.Revision surgical report dated (b)(6) 2018: diagnosis: fracture of ceramic head left hip joint.Procedure: cup exchange to tm cup, 36 inlay and biolox option head m 12/14.During surgery, smaller pieces of ceramic are removed and 4 large pieces can be retrieved.Difficulties removing the inlay.This might have caused damage to the cup, therefore indication for cup removal.Implantation of 54 tm cup and inlay.X-ray control show good positioning.However, stem got jammed dorsally, during luxation cup comes loose.Inlay removed.Cup has no damages and is reinserted.Impaction of a new 36 inlay.Size s head leads to difficulties during repositioning.Impaction of size s head.Soft tissue laxity and luxation tendency.Removal of size s head and impaction of biolox option size m head.No luxation tendency.Doctor letter dated 29 dec 2017: today patient head a suddon noise in the area of the trochanter major.Pain.No trauma.X-ray control showed good positioning, no fracture or luxation.Doctor letter dated 10 jan 2018: femoral head fracture, implant failure.Devices analysis no product was returned to zimmer biomet for in-depth analysis.Review of product documentation all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.No ncr was found.Raw material certificate reviewed and found to be conforming.Conclusion summary patient underwent revision surgery due to ceramic head fracture after approx.2 years in-vivo time.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the given information the complaint could not be confirmed and no specific root cause could be determined for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed again.Zimmer biomet¿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 submitted to relay updated information as the returned device has been investigated and the conclusion has been updated.Investigation results were made available.D11: fitmore, hip stem, uncemented, a/6, taper 12/14; ref:01.00551.106; lot:2774775.Allofit it alloclassic, shell for acetabulum, uncemented, 54/jj; ref:00875505400; lot:2800558.Liner neutral 32 mm i.D.Size jj for use with 54 mm o.D.Size jj shell; ref:00875101132; lot:63044205.Event description: it was reported that a female patient had an implantation of a total endoprosthesis of the left hip on (b)(6) 2016 (cementless).On (b)(6) 2017 the patient sat on the couch with stretched out legs and in a relaxing position.Her neck was supported by a pillow.Suddenly the patient heard a loud noise.As the patient tried to stand up there was an instant pain in the area of the left hip.The patient went to hospital but there couldn't be found out what the origin of the pain was.It just was given analgesics and it was said that the patient should await the following weekend (with the turn of the year).But the pain wasn't getting better and so the patient went to hospital on (b)(6) 2017 again.She underwent a revision surgery on (b)(6) 2018.Review of received data: primary surgery report is reviewed.No operative details were available.Attorney letter is reviewed.Additional documents received on 04 may 2020: doctor letter dated (b)(6) 2015: diagnosis: coxarthrosis on both sides, left more significant.Doctor letter dated (b)(6) 2015: medium degree of coxarthrosis left and right hip joint radiological report dated (b)(6) 2016: pelvic overview from (b)(6) 2016: progressed coxarthrosis, left more than right hip joint.Radiological report dated (b)(6) 2016: pelvic overview from (b)(6) 2016: hip prosthesis with short stem, good articulation and good cup inclination angle of approx.42 degrees.No material fracture, no periprosthetic fracture.Pictures of explants: six pictures showing the 5 large fragments were received, however, the quality is low.There is metal transfer visible on all fragments, at the taper area as well as the fracture surface.Moreover, one picture shows the outer surface explanted allofit cup, which has some presumably bone attachment on it.Revision surgical report dated (b)(6) 2018: diagnosis: fracture of ceramic head left hip joint.Procedure: cup exchange to tm cup, 36 inlay and biolox option head m 12/14.During surgery, smaller pieces of ceramic are removed and 4 large pieces can be retrieved.Difficulties removing the inlay.This might have caused damage to the cup, therefore indication for cup removal.Implantation of 54 tm cup and inlay.X-ray control show good positioning.However, stem got jammed dorsally, during luxation cup comes loose.Inlay removed.Cup has no damages and is reinserted.Impaction of a new 36 inlay.Size s head leads to difficulties during repositioning.Impaction of size s head.Soft tissue laxity and luxation tendency.Removal of size s head and impaction of biolox option size m head.No luxation tendency.Doctor letter dated (b)(6) 2017: today patient head a sudden noise in the area of the trochanter major.Pain.No trauma.X-ray control showed good positioning, no fracture or luxation.Doctor letter dated (b)(6) 2018: femoral head fracture, implant failure.Intraoperatively light degree of inflammated capsule tissue taken.No sign of infection.Anamnesis: patient came to emergency on (b)(6) 2017 after hearing a sudden loud noise in the left hip joint.Since then patient complaints about pain.No clear implant failure could be detected.Patient returned in emergency on (b)(6) 2017.Patient and husband report loud noise while patient lay on couch.Pain.Indication for revision.X-ray control (b)(6) 2017: femoral head fracture.No clear fracture or luxation visible.No clear signs of loosening.Devices analysis: visual examination: the ceramic femoral head is fractured into several pieces.Therefore, the reported event of the fracture can be confirmed.The articulation surface exhibits slight metallic smearing in form of lines and dots.The head taper does not show the commonly observed seating pattern which would indicate a proper seating of the head on the stem taper.Other than that nothing conspicuous can be observed.The explanted cup has also been recieved.There is some bone attachment on the anchoring side.The inner surface has several damages, which might have occurred during explantation.See pictures attached.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.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.No ncr was found.Raw material certificate reviewed on: 04-jun-2020 and found to be conforming.Conclusion summary: patient underwent revision surgery due to ceramic head fracture after approx.2 years in-vivo time without having experienced any trauma.The investigation results did not identify a non-conformance or a complaint out of box (coob).The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Based on the visual examination of the explants, the reported event of the femoral head fracture can be confirmed.It was found that the head taper does not show the commonly observed seating pattern which would indicate a proper seating of the head on the stem taper.Inproper seating of the femoral head on the stem might have caused or contributed to the fracture of the femoral head.However, based on the available information, an exact root cause for the femoral head fracture cannot be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed again.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Investigation has been updated.
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Search Alerts/Recalls
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