MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 16X152MM; PROSTHESIS, HIP

Catalog Number	51-104160
Medical Device Problem Codes	Difficult to Insert (1316); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 650-1058 cer bioloxd option hd 40mm lot #:3213632, unknown adapter h6: mechanical code: stem.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 that the adapter may not have seated correctly on the stem.Caused the head to potentially sit higher than it should have, so doctor was unable to reduce hip.There was roughly a 10-15 minute delay as the surgeon was unable to reduce the patient¿s hip.He tried to separate the head/taper from the stem, but the taper remained on the stem while the head separated from the taper.He had to replace that stem with a new stem as the taper would not disengage.The procedure was completed using a new stem.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.The complaint cannot be confirmed.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.
Event or Problem Description
There is no additional information available at the time of this report.

• Brand Name: TPRLC 133 T1 PPS HO 16X152MM
• 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: 21558599
• Report Number: 0001825034-2025-00611
• Device Sequence Number: 9127411
• Product Code: LZO
• UDI-Device Identifier: 00880304491854
• UDI-Public: (01)00880304491854(17)310414(10)6994024
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 51-104160
• Device Lot Number: 6994024
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Patient Age: 42 YR
• Patient Sex: Male