MAUDE Adverse Event Report: Zimmer Biomet, Inc. TPRLC XR T1 PPS 17X154MM; Prosthesis, Hip

Catalog Number	51-105170
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
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 evaluation of the returned product confirms item and lot label identification.Cavity was found sealed and unopened in the carton.Cavity shows indentation damage and was not considered breached.Cavity was opened to inspect the pouch and confirmed the pouch was punctured and breach confirmed.No other damage was noted.Review of the device history record 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: TPRLC XR T1 PPS 17X154MM
• 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: 50525082
• Report Number: 0001825034-2026-02619
• Device Sequence Number: 6040357
• Product Code: LPH
• UDI-Device Identifier: 00880304517189
• UDI-Public: (01)00880304517189(17)260816(10)3857249
• 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): 08/31/2026

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 Expiration Date: 08/16/2026
• Device Catalogue Number: 51-105170
• Device Lot Number: 3857249
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2026
• 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: 04/09/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown