MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, L, 36/+3.5, TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products and therapy date.Detail of product: item number 00630505636.Item name liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell.Lot # 63279862.Item number 00786201300.Item name femoral stem fiber metal taper collarless 12/14 neck taper size 13 standard body standard neck offset.Lot # 62101618.Item number 00620005622.Item name shell porous with cluster.Lot # 62076918.The manufacturer did not receive x-rays but received other source documents for review.The device has not been received for investigation as the patient has not been revised.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is 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).
Event or Problem Description
A patient is pursuing a product liability claim following a spontaneous hip dislocation of the head and liner of the right hip one year post-op.Patient was reduced under sedation.
Additional Manufacturer Narrative
Event description: it was reported that the patient underwent initial right total hip arthroplasty on (b)(6)2012.The patient was revised on (b)(6) 2018 due to recurrent dislocation and complications from trunnionosis.During the revision, it was noted that severe tissue damage left no abductor function in the hip.The patient subsequently dislocated again and was successfully reduced in the er on (b)(6) 2019.No further plan for revision has been reported at this time.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Review of received documents: - complication: patient experienced a spontaneous hip dislocation one year post head and liner right hip revision.- (b)(6) 2018; mri right hip no acute bone finding, no fracture or contusion, large right hip joint effusion with marked capsular thickening and synovitis.- (b)(6) 2018; right hip revision; during that procedure, (b)(6) found tissue notable for significant grey appearance with fronds and severe loss of abductors.The posterior half of the greater trochanter was completely bare.There were significant amounts of pseudotumor encapsulating the joint and extending along the lateral aspect of the proximal femur.The trunnion was stained black.- (b)(6) 2018; post-revision visit note 2 weeks postop, slight pain, slight limp, using cane, healing well.Pathology report from revision revealed no growth in cultures in addition to acellular debris consistent with metallosis.- (b)(6) 2018; disability note patient placed on permanent disability.- (b)(6) 2019; ed note re right hip patient presented to er after twisting in bed this morning, felt like he dislocated, first issue he has had with right hip since revision.Tenderness over right groin and right lateral hip, ir and shortening of the rle, distal neurovascularly intact.Closed reduction under sedation performed without complication.Post-reduction x-ray confirmation obtained.Patient discharged home ambulatory, follow up outpatient with (b)(6).- (b)(6) 2019; 1-year post-revision visit continues to walk with a cane, aware of trendelenburg limp, vague sense of discomfort since reduction but feels this is improving, no further feeling of instability.Stable, no pain, full passive rom.Reminded the patient he remains at high risk for dislocation as he has no abductor function for the posterior half of his greater trochanter.No plans for further intervention at this time.Product evaluation: the biolox head remains implanted; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient underwent initial right total hip arthroplasty on (b)(6) 2012.The patient was revised on (b)(6) 2018 due to recurrent dislocation and complications from trunnionosis.During the revision, it was noted that severe tissue damage left no abductor function in the hip.The patient subsequently dislocated again and was successfully reduced in the er on (b)(6) 2019.No further plan for revision has been reported at this time.Based on the received medical records the reported dislocation can be confirmed.No x-ray images have been received, therefore, the patient's anatomy and implant positioning as well as changes of the mentioned factors over time could not be evaluated.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, it is possible that the insufficient abductor muscles led or contributed to the reported event, nevertheless, as the cause may be multifactorial consisting of implant (size, type of implant), patient (muscular insufficiency, weight) and procedure (surgical procedure, implant positioning) related factors we were not able to identify a specific root cause for the dislocation.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).
Event or Problem Description
No change to previously reported event.

• Brand Name: BIOLOX OPTION, HEAD, L, 36/+3.5, TAPER 12/14
• Common Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9942422
• Report Number: 0009613350-2020-00187
• Device Sequence Number: 3882095
• Product Code: LZO
• UDI-Device Identifier: 00889024430532
• UDI-Public: 00889024430532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-03
• Device Lot Number: 2764132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 107