MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE XR 123 MICRO FEMORAL MP T1 PPS 13X111MM; PROSTHESIS, HIP

Catalog Number	51-145130
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inspecting circulated items, there was debris found in the sterile packaging.There was no patient involvement, and it was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.Evaluation of the photographs provided/returned product confirmed there is white debris inside the sterile packaging which is visually consistent with the appearance of foam debris from the foam packaging.Additional evaluation of the returned product found damage to the sterile packaging (pouch).Sterility has been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.A corrective action has previously been initiated to implement improved packaging changes.The reported event has been confirmed by evaluation of the provided photos and returned product.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: TAPERLOC COMPLETE XR 123 MICRO FEMORAL MP T1 PPS 13X111MM
• 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 ; 5745260384
• MDR Report Key: 22829184
• Report Number: 0001825034-2025-02494
• Device Sequence Number: 4463985
• Product Code: LPH
• UDI-Device Identifier: 00880304517325
• UDI-Public: (01)00880304517325(17)260225(10)3739731
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2026
• Device Catalogue Number: 51-145130
• Device Lot Number: 3739731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2016
• 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
• Patient Sex: Unknown