MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER EXT; PROSTHESIS, HIP

Catalog Number	00811400110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 1-month post implantation due to a suspected post operative infection.During the procedure, the surgeon noted that there was a fracture of the greater trochanter which was not evident on x-ray.May have indicated a fall or might be related to infection.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
(b)(4).D10: zb 12/14 cocr hd 28mm x +0.Item: 802202802.Lot: 3244977.Shell 52 mm o.D.Item: 00500105200.Lot: 66539928.Liner 28 mm i.D.For use with 50/51/52 mm o.D.Shells.Item: 65840273.Lot: 00500105028.G2: foreign ¿ australia.H6: proposed component code: mechanical (g04) ¿ stem.The product was requested but was not returned by the hospital and will therefore not be sent to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr ponce - 2648920.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr ponce - 2648920.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXT
• 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: 23977140
• Report Number: 0001822565-2026-00082
• Device Sequence Number: 11919951
• Product Code: JDI
• UDI-Device Identifier: 00889024145764
• UDI-Public: (01)00889024145764(17)340421(10)66635219
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/15/2026

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: 00811400110
• Device Lot Number: 66635219
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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 Sex: Male