MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM; PROSTHESIS, HIP

Catalog Number	802202802
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a hip revision approximately thirteen months post implantation for unknown reasons.The bearing, stem and head were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat #: ep-200148 / act artic e1 hip brg 28x42mm / lot #: 483760; cat #: 00811400200 / femoral stem 12/14 neck taper std.Offset size 2 130 mm stem length / lot #: 65179060.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-02587.0002648920-2024-00346.Proposed component code: mechanical (g04)-head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint could not be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20609963
• Report Number: 0001822565-2024-03478
• Device Sequence Number: 7930104
• Product Code: LPH
• UDI-Device Identifier: 00889024498785
• UDI-Public: (01)00889024498785(17)310331(10)306874
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 802202802
• Device Lot Number: 3068754
• Was Device Available for Evaluation?: No
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female