MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 7.0; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Catalog Number	51-101070
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	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the implant was found protruding from the inner sterile plastic peel pack upon inspection, while the outer package appeared undamaged and the foam protective layer was in place; the implant was not accepted for use.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d9; g3; h2; h3; h6 visual examination of the returned cartons confirmed item and lot label identification.The pouch is breached due to a hole punctured through it allowing the stem to partially stick out.No other damage was noted.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.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.

• Brand Name: TPRLC 133 FP TYPE1 PPS HO 7.0
• Common Device Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
• 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: 24746143
• Report Number: 0001825034-2026-00795
• Device Sequence Number: 9376725
• Product Code: KWA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: Health Professional
• Device Expiration Date: 06/27/2026
• Device Catalogue Number: 51-101070
• Device Lot Number: 3817414
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2026
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2016
• 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
• Patient Sex: Unknown