MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, L, 28/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS OPTION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received medical records and will be reviewed as part of ongoing investigation.The manufacturer did not receive 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
It was reported that subsequently, the patient was revised due to unknown reasons.The cup, head and bearing were removed and replaced.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Investigation has been completed.Investigation and conclusion: event description: it was reported that patient underwent an initial left total hip arthroplasty subsequently, the patient was revised due to unknown reasons.The cup, head and bearing were removed and replaced.Harm: s3 - exposure to anesthesia, moderate.Hazardous situation: unknown.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.Product evaluation: visual examination: the complaint product was returned and received at the warsaw site for examination.A visual examination was performed on behalf of the warsaw team and the ceramic head was noted to have scratches on the lip of the taper and signs of wear to the outer diameter.Review of product documentation: device purpose: all involved devices are intended for treatment.Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that patient underwent an initial left total hip arthroplasty subsequently, the patient was revised due to unknown reasons.The cup, head and bearing were removed and replaced.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 reported event cannot be confirmed as the nature and details of the event are unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
Investigation results are now available.Attempts have been made and no further information has been provided.

• Brand Name: BIOLOX OPTION, HEAD, L, 28/+3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEADS OPTION
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13692785
• Report Number: 0009613350-2022-00132
• Device Sequence Number: 5111203
• Product Code: LZO
• UDI-Device Identifier: 00889024430457
• UDI-Public: 00889024430457
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-028-03
• Device Lot Number: 2978521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male