MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, M, 28/0, TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number	N/A
Medical Device Problem Codes	Degraded (1153); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: unknown stem; catalog#: unknown; lot#: unknown act artic e1 hip brg 28x40mm s46 dia28; catalog#: ep-200146; lot#: 511660.Therapy date: (b)(6) 2021.The manufacturer received other source documents for review.The manufacturer received the device for investigation.Where lot numbers were received for the 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).
Event or Problem Description
Patient was implanted on an unknown side and underwent a revision surgery due to excessive scuffing present on the dual mobility bearing.The patient had a fall and fractured distally the stem.The femoral fracture is marked as contributing condition for this scuffing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that patient underwent total hip arthroplasty on (b)(6) 2020.Subsequently, the patient was revised on (b)(6) 2021 due to femoral fracture distally of the stem after the patient experienced a fall.During the revision, excessive scuffing was found on the dual mobility bearing.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination:the biolox head has some metal smears on the rim and light scratches on the edge of the metal sleeve.The ceramic articulating surface is inconspicuous.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the overall compatibility check could not be performed as not all involved devices are known.The combination of the returned head and bearing 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 patient underwent total hip arthroplasty on (b)(6) 2020.Subsequently, the patient was revised on (b)(6) 2021 due to femoral fracture distally of the stem after the patient experienced a fall.During the revision, excessive scuffing was found on the dual mobility bearing.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).The visual examination of the biolox head shows minimal signs of wear consisting of metal smears and light scratches on the metal sleeve, which do not affect the device performance.The examination revealed that the revision of the head was due to the femur fracture resulting from the patient's fall.The need for corrective measures is not indicated and zimmer switzerland manufacturing 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, M, 28/0, TAPER 12/14
• Common Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11885405
• Report Number: 0009613350-2021-00237
• Device Sequence Number: 3709898
• Product Code: LZO
• UDI-Device Identifier: 00889024430440
• UDI-Public: 00889024430440
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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 Model Number: N/A
• Device Catalogue Number: 00-8777-028-02
• Device Lot Number: 2995207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 10/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR