MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HEAD, 12/14, 36 X 0; BIOLOX DELTA CERAMIC FEMORAL HEAD

Catalog Number 00-8775-036-02

Device Problems Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333); Joint Dislocation (2374)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received for investigation as the patient has not been revised.Where lot numbers were received for the device, the device history record were reviewed and found to be conforming.As soon as additional information become available and an investigation result be available an updated report will be submitted.The need for corrective measures is not indicated at this time.(b)(4).This is a split case with (b)(4) for the devices manufactured by zimmer inc.Note: this is a split case with (b)(4) for the devices manufactured by zimmer inc.As patient experienced same problems for the right side, (b)(4) (zimmer (b)(4) devices) and (b)(4) (zimmer inc.Devices) are field.

Event Description

A patient is pursuing a product liability claim.It is reported that a patient was implanted a biolox delta head, 12/14, 36 x 0 on (b)(6) 2011 on the left side.It is also reported that patient is experiencing consistent and gradually increasing pain in the groin and surrounding regions, stiffness, grinding of the implant, and squeaking of the implant, among other things.Also, patient suffers from metallosis.A revision surgery is planned for unknown date.Patient has bilateral hip replacement and is experiencing same problems on both sides.

Manufacturer Narrative

Dhr review: dhr records were reviewed and found to be conforming.Trend analysis: no trend identified.Review of incoming information according to the legal letter the patient have been suffering from extreme pain as well as swelling and limited mobility due to metallosis since (b)(6) 2013.The law firm asssumes that the metallosis was caused by micro friction between stem and neck part of the m/l taper, which was implanted in 2011.A biolox delta head was implanted along with the m/l taper stem.No x-rays, pictures or surgical notes were provided a legal letter was received.Devices analysis: a device analysis was not performed as no product was available for investigation.Possible causes for the reported event according to dfmea: increased chemical, galvanic or crevice corrosion and / or fretting of material, metal ion release from stem taper due to micromotion due to increasd frictional moment, corrosion; increased wear due to foreign particles in cop and coc pairing; release of corrosion particles of stem taper due to inadequate material pairing; release of metal ions from stem taper due to inadequate material pairing; increased chemical, galvanic or crevice corrosion and fretting corrosion on taper connection due to insufficient material resistance; mal-function of tha (wear, fracture, dislocation etc.) due to wrong size of head diameter and/or offset, wrong taper size combination; increased chemical, galvanic or crevice corrosion and / or fretting of material, metal ion release due to not allowed/ wrong combination of zimmer products; mal-function of tha (wear, fracture, dislocation etc.) -> due to off label use, combination with competitor products; increased wear, fretting corrosion on stem taper (lever torque) due to patient with high body weight.Comparison to investigation results whether it is possible and justification: possible as no product or pictures were available; possible as no product or pictures were available; not possible as material pairing is approved by compatibility specification; not possible as material pairing is approved by compatibility specification; not possible as material compatibility specification certify the suitability of the material; possible as the surgical technique for m/l stems with kinectiv technology states "the m/l taper hip prosthesis with kinectiv technology can be used with several head diameters and bearing surfaces.Select the +0 femoral head size and bearing surface based on surgeon preference." 0/m head was used in this case which is correct.However, no x-rays were available to consider the correct head size; not possible as the product combination is approved by zimmer (b)(4); not possible as the product combination is approved by zimmer (b)(4); possible as weight unknown based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.New information received: - winterthur product; biolox head was not explanted.Concomitant medical products: item: shell porous with multi holes 54 mm catalog #: 00620205420 lot #: 61534502, item: modular femoral stem press-fit plasma catalog #: 00771300900 lot #: 61757652, item: liner standard 3.5 mm offset 36 mm i.D.Catalog #: 00630505036 lot #: 61841306, item: shell porous with multi holes 60 mm catalog #: 00620206020 lot #: unknown, item: liner standard 3.5 mm offset 36 mm i.D catalog #: 00630506036 lot #: unknown, item: trabecular metal acetabular revision system catalog #: 00489405010 lot #: unknown.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was now reported that during revision surgery due to fracture of acetabular component, dislocation and metallosis, only cup and liner was exchanged.The winterthur product: biolox delta, ceramic femoral head, m, 36/0, taper 12/14 was retained.Note: as bilolox head was not explanted, the field "d7" is now empty.

Manufacturer Narrative

The case was reopened as additional information was received and is filed in this report.The case will be reevaluated and reassessed.As soon as additional information and/or investigation results are available an updated medwatch 3500a will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

A legal claim was raised.It is reported that a patient was revised about 5 years post-implantation due to pain, metallosis and dislocation.

Manufacturer Narrative

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.Event description: event summary: it is reported that patient experiences consistent and gradually increasing pain in the groin and surrounding regions, stiffness, grinding of the implant, and squeaking of the implant, among other things.Also, patient suffers from metallosis.Review of received data: doctor office notes dated (b)(6) 2016: radiographs are stated to demonstrate catastrophic failure on the left hip.Hip is dislocated.Acetabular seems to have gone fracture and failure.Severe metallosis throughout the soft tissues of hip.X-ray report dated (b)(6) 2016: dislocation at the level of proximal left femoral component relative to the acetabular component.No fractures.Heterotopic bone and cement suspected at the level of the hip.Primary surgery report dated (b)(6) 2011: pre-op diagnosis: left hip dysplasia and severe degenerative joint disease.Morbid obesity.Surgeon had a significant discussion whit patient regarding the fact that due to her young age and weight she will wear out the thr and multiple surgeries will be wanted in future.She understood and wanted to proceed.Zimmer implants were implanted with success.Severe dysplasia required 3 screws to fix the acetabular cup.All components were in good condition.Revision surgery dated (b)(6) 2016: preoperative diagnosis: catastrophic failure, left hip arthroplasty with severe metal ion accumulation within the hip.Operation: ceramic head completely eroded through acetabular shell.Massive ti deposition at the hip with soft tissue destruction.Severe acetabular bone loss.The patient is also morbidly obese increasing the difficulty of the procedure.No proximal support as the head had eroded right through the proximal bone.A 60 cup was then impacted.It got secure fixation proximally against augment.Screw augmentation done.Neutral liner for 32 was selected.A 16 x 190 red apt stem was utilized.Neutral ball.Although this resulted in clinical limb lengthening, it did provide stability to the hip.According to the legal letter the patient is suffering since (b)(6) 2013 from extreme pain as well as swelling and limited mobility due to metallosis.The law firm assumes that the metallosis was caused by micro friction between stem and neck part of the m/l taper (zb warsaw), implanted in 2011.A biolox delta head (zb winterthur) was implanted along with the m/l taper stem.Pathology report from the revision surgery dated (b)(6) 2016: portion of fibrocollagenous tissue with abundant small black particle-laden histiocytes.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: no product documentation was reviewed for investigation.Root cause analysis: root cause determination using sap rmw: failure of connection between stem and ball head, dislocation, subluxation, abrasive wear due to inadequate taper connection design leads to dissociation of the ceramic head (taper connection not able to resist the impaction force) not possible a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, dislocation, subluxation, abrasive wear due to inadequate head design leads to impingement; limited range of motion not possible a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, dislocation, dissociation, implant breakage due to insufficient connection strength between head and stem due to insufficient material properties and/or design not possible a systematic issue with design and/or aterial properties would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, postoperative tissue reaction, metalosis, dislocation, dissociation, aseptic loosening of stem, osteolysis due to insufficient connection strength / micromotion leading to wear in taper connection between stem and head not possible a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assesment postoperative tissue reaction, metalosis, dislocation, aseptic loosening of stem, osteolysis due to pe, ceramic or metal particle release from articulation (head and inlay) or taper (head and stem) connection due to wear possible, head is reported to be worn significantly, most possibly due to contact with metallic shell.Failure of connection between stem and ball head, dislocation, subluxation, dissociation, abrasive wear, limited rom, impingement due to inadequate head and/or adapter design leads to impingement (component to bone) with stem not possible a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Failure of connection between stem and ball head, dislocation, subluxation, abrasive wear due to impingement (component to bone, component to component, component to soft tissue) due to malposition of components (stem, head, cup) possible, no x-rays were received to confirm, therefore cannot be excluded.Dislocation, subluxation, leg length discrepancy, aseptic loosening of components due to selection of wrong components (e.G.Wrong size of head diameter and/or offset) not possible the surgical technique for m/l stems with kinectiv technology states the m/l taper hip prosthesis with kinectiv technology can be used with several head diameters and bearing surfaces.Select the +0 femoral head size and bearing surface based on surgeon preference.0/m head was used in this case which is correct.Failure of connection between stem and ball head, implant breakage, corrosion, metalosis, dislocation, subluxation, abrasive wear due to head is implanted on a damaged stem taper; usage of a wet and/or unclean stem and/or head taper (particles between stem taper and ball head taper) possible, cant be confirmed, therefore cannot be excluded.Failure of connection between stem and ball head, abrasive wear, fretting corrosion, dislocation, dissociation, implant fracture, soft tissue impingement due to inappropriate assembling of head with stem (e.G.Insufficient impaction force and/ or off axis impaction, torque on head) possible, cant be confirmed, therefore cannot be excluded.Dislocation, subluxation, abrasive wear, leg length discrepancy, impingement, limited range of motion due to soft tissue laxity possible, it is not reported, however cannot be excluded.Failure of connection between stem and ball head, abrasive wear, dislocation, subluxation, fracture of head, leg length discrepancy due to off label use; wrong combination of components used; combination with competitor products not possible product combination was allowed.Dislocation, subluxation, aseptic loosening due to inappropriate information on packaging label or not legible packaging label leads to incorrect use of implant not possible ifu d011500245 (chapters: "indications" and "warnings") provides the necessary and appropriate information.Failure of connection between stem and ball head, abrasive wear, dislocation, subluxation, fracture of head due to laser marking not readable in normal lighting conditions leads to use of wrong head not possible dhr of the product shows released components met all requirements to perform as intended.Implant breakage, dislocation due to inappropriate advice by surgeon to inform patient on postoperative activities and limits.Possible, cant be confirmed, therefore cannot be excluded.Conclusion: according to the event the patient underwent revision surgery of her thr after 5 years 1 month in-vivo time due to dislocation.During the revision it was found that the ball head was eroded massively and severe metal ion accumulation within the hip was found.Most probable explanation of the worn out of the head is that after the hip was dislocated due to some unknown reasons, the head was in contact with the metallic shell which led to catastrophic wear of head and metallic shell.It is possible that the pe liner was also dislocated from the shell and the head was for some time located in the acetabular shell socket.Raw material certificate confirms that the device was manufactured according to the material specifications.Review of the device history records for the product did not identify any deviations or anomalies related to the reported event.Possible reasons of the total failure event include pe, ceramic or metal particle release from articulation (head and inlay) or taper (head and stem) connection due to wear, impingement (component to bone, component to component, component to soft tissue) due to malposition of components (stem, head, cup), wrong assembly of the head on the stem taper, use of damaged stem/head, soft tissue laxity, inappropriate advice by surgeon to inform patient on postoperative activities and limits and high patient body weight (patient is obese).It is also possible that the fact that the patient fell 6 days post-op the position of the liner or cup might have slightly changed which initiated the start of the dislocation phenomena that is seen later on.However, based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.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).

Manufacturer Narrative

Additional information was received and is filed in this report.The investigation of this event is ongoing and will be updated accordingly.As soon as additional information and/or investigation results become available an updated medwatch will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was now reported that the device was explanted during revision surgery.

• Brand Name: BIOLOX DELTA HEAD, 12/14, 36 X 0
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 5349936
• MDR Text Key: 35207672
• Report Number: 9613350-2016-00010
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2597820
• Other Device ID Number: 00889024430365
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 260