MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 51-109070 tloc 133 mp sp t1 pps ho 7x99 j7635314.Suggested component code: mechanical (g04) ¿ stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 after opening the implant that the inside of the package had been damaged as if the implant was moving around inside.It was reported after opening the stem, particles were present and assumed to be metal but could not be determined.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2; h3; h4; h6.The following sections were corrected: d1; h6 component code.The device was returned for evaluation with no packaging.No damage to the device was noted.Visual evaluation of the provided photos identified damage to the sterile packaging (pouch) with the presence of black porous coating debris.Sterility has been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported event can be attributed to transit damage and a packaging design issue.Complaint is confirmed.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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: TAPERLOC COMPLETE
• Common Device Name: PROSTHESIS, HIPS
• 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: 22643579
• Report Number: 0001825034-2025-02300
• Device Sequence Number: 12931960
• Product Code: KWA
• UDI-Device Identifier: 00880304513013
• UDI-Public: (01)00880304513013(17)260929(10)3886220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 09/29/2026
• Device Model Number: N/A
• Device Catalogue Number: 51-109070
• Device Lot Number: 3886220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown