MAUDE Adverse Event Report: Zimmer Biomet, Inc. TAPERLOC COMPLETE XR 123 MICRO FEMORAL; Prosthesis, hip

Catalog Number	51-145100
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 9 months post-implantation, the patient underwent a hip revision due to a femoral fracture.The stem and head were revised; the stem may have been undersized.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: cat# 650-0661 lot# 3233263, g2: foreign ¿ event occurred in australia, h6: proposed component code: mechanical (g04) - stem.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.

• Brand Name: TAPERLOC COMPLETE XR 123 MICRO FEMORAL
• Common Device Name: Prosthesis, hip
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50546957
• Report Number: 0001825034-2026-02642
• Device Sequence Number: 10318529
• Product Code: LPH
• UDI-Device Identifier: 00880304517295
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 09/01/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 51-145100
• Device Lot Number: 7118681
• 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: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female