MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 5.0; PROSTHESIS, HIP

Catalog Number	51-101050
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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while pulling expired implants at the distributors office that the stem was protruding through the box and internal packaging.There was no patient involvement.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).Visual evaluation of the returned product/provided photos identified damage to the sterile packaging (blister and pouch).Sterility has been compromised.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: TPRLC 133 FP TYPE1 PPS HO 5.0
• 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 ; 5745260384
• MDR Report Key: 24190650
• Report Number: 0001825034-2026-00222
• Device Sequence Number: 9850865
• Product Code: KWA
• UDI-Device Identifier: 00880304499065
• UDI-Public: (01)00880304499065(17)260203(10)3721978
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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: 02/03/2026
• Device Catalogue Number: 51-101050
• Device Lot Number: 3721978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown