MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD +0X28MM DIA; PROSTHESIS, HIP

Catalog Number	00-8018-028-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - head.D10: cat#: 00-8114-001-10, lot#: 66695055 cpt 12/14 size 1 cocr ext.Cat#: 00-5001-055-00, lot#: 65840289 multipolar bipolar cup.Cat#: 00-5001-053-28, lot#: 65624029 liner assy 53/54/55od x 28id.G2: foreign: australia.This report was previously reported under the wrong mfr: 0001822565-2025-04407-1.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient was revised approximately 13 years later due to infection.The cpt bipolar head was explanted.Attempts have been made and no further information has been provided.

• Brand Name: FEMORAL HEAD +0X28MM DIA
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• 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: 24887706
• Report Number: 0002648920-2026-00059
• Device Sequence Number: 18616252
• Product Code: JDI
• UDI-Device Identifier: 00889024144620
• UDI-Public: (01)00889024144620(17)291130(10)64558257
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K840643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: Lay User/Patient
• Device Catalogue Number: 00-8018-028-02
• Device Lot Number: 64558257
• 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: 04/08/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male