MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 12X144MM; PROSTHESIS, HIP

Catalog Number	51-103120
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that debris was found inside the sterile packaging of the taperloc implant.The debris was a red foreign material resembling a string.No health consequences or impact as a result.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).The customer indicated that the product was used; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.Visual evaluation of the provided photo found the packaging was previously opened.An unknown red fiber was found in the sterile packaging.As the product was previously opened, the source of the debris cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.
Event or Problem Description
No additional information available for the reported event.

• Brand Name: TPRLC 133 T1 PPS SO 12X144MM
• 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: 23543483
• Report Number: 0001825034-2025-03595
• Device Sequence Number: 21153269
• Product Code: LZO
• UDI-Device Identifier: 00880304491823
• UDI-Public: (01)00880304491823(17)350121(10)J7888781
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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 Catalogue Number: 51-103120
• Device Lot Number: J7888781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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: Female