MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 14X148MM; PROSTHESIS, HIP

Catalog Number	51-104140
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H6 proposed component code: mechanical (g04) - stem.The reported product has been returned to zimmer biomet for analysis.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial hip procedure, the surgeon impacted the distal stem and then extracted the implant using the standard surgical technique.Upon extraction, it was observed that the beads on the porous coating were flaking off.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b1; b2; d4; d5; g3; h1; h2; h3; h4; h6.Visual examination of the returned product identified the porous coating when rubbed with a gloved hand produced flaking/debris of the porous coating.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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
The patient did have some retained coating from the stem.The surgeon successfully completed surgery with a new stem.No additional information available for the reported event.

• Brand Name: TPRLC 133 T1 PPS HO 14X148MM
• 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: 22327659
• Report Number: 0001825034-2025-01844
• Device Sequence Number: 15848724
• Product Code: LZO
• UDI-Device Identifier: 00880304491847
• UDI-Public: (01)00880304491847(17)330904(10)7606230
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 51-104140
• Device Lot Number: 7606230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male