MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH BIOLOX® OPTION, HEAD, M, ø 36/0, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 2-year post-implantation, the patient underwent revision surgery due to implant fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Report source- foreign: italy.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, d10, g3, g6, h1, h2, h3, h4, h6, h10.D10- unknown liner, item# unknown , lot# unknown multiple mdr reports were filed for this event, please see associated reports: 0009613350 -2022 -00677.No product was returned or pictures provided: product evaluation could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical record were provided and reviewed.Patient is female, age 68 at the moment of revision.Initial tha in 2016 and first revision in 2020 for fractured insert.During revision, surgeon assessed that stem and acetabular cup were found to be well positioned and osteointegrated.Products were not returned for investigation and pictures were not provided therefore device evaluation could not be performed.At the moment of manufacturing, the head respected design specification.No information on manufacturing records could be reviewed on the insert, as item and lot number were not provided.With the available information a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX® OPTION, HEAD, M, ø 36/0, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER MANUFACTURING SWITZERLAND 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: 15652241
• Report Number: 0009613350-2022-00556
• Device Sequence Number: 19440110
• Product Code: LZO
• UDI-Device Identifier: 00889024430525
• UDI-Public: (01)00889024430525(17)271231(10)2935402
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2022

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-02
• Device Lot Number: 2935402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 12/09/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/14/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE COMMENTS IN H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female