MAUDE Adverse Event Report: Zimmer Biomet, Inc. TPRLC 133 MP TYPE1 PPS SO 17.0; Prosthesis, Hip

Catalog Number	51-106170
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that damaged sterile packaging 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 product identifies that all the devices had creasing and tearing on the pouches at the pre-tear.Pouch seal width measured less than 6mm for all devices and are not acceptable.No other damage was noted during visual evaluation.Review of the device history records identified no deviations or anomalies during manufacturing.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: TPRLC 133 MP TYPE1 PPS SO 17.0
• 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: 50370290
• Report Number: 0001825034-2026-02454
• Device Sequence Number: 5765607
• Product Code: KWA
• UDI-Device Identifier: 00880304514416
• UDI-Public: (01)00880304514416(17)320711(10)7287915
• 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): 08/21/2026

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: 51-106170
• Device Lot Number: 7287915
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2026
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown