MAUDE Adverse Event Report: Zimmer Biomet, Inc. TLOC 133 MP SP T1 PPSHO 6X97.5; Prosthesis, Hip

Catalog Number	51-109060
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that damaged sterile packaging pouch was identified during inspection of circulated stock items.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).G2: foreign, japan.Visual examination of the returned cartons confirmed item and lot label identification.Cavities were opened to evaluate the pouch and pre-tear.Pouch seal widths were measured and were less than the acceptable 6mm per.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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 trends.

• Brand Name: TLOC 133 MP SP T1 PPSHO 6X97.5
• 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: 50772859
• Report Number: 0001825034-2026-02773
• Device Sequence Number: 10615016
• Product Code: KWA
• UDI-Device Identifier: 00880304512993
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110400
• 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): 09/15/2026

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: Other
• Device Catalogue Number: 51-109060
• Device Lot Number: 6795230
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown