MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 7.0; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Implant subsidence (4078)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon implanted a standard offset size 7 femoral stem.The patient subsequently experienced hip dislocation, prompting follow-up x-rays.Upon reviewing the images, the surgeon noted that the femoral stem had subsided further into the femur.Surgeon believes that the stem size selected may have been inappropriate for the patient.A revision surgery was performed.During the procedure, the original stem was removed and replaced with a taperloc complete standard offset size 10 cemented femoral stem.Attempts have been made and no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 010000927 g7 hi-wall e1 liner 32mm e 7588718.163667 32mm mod head cocr -6mm neck j7880193.G2: foreign: ireland.Suggested component code- mechanical (g04): stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Corrected: h4.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It was noted that there may have been a sizing issue with the stem, however no x-rays or medical records were provided therefore no definitive statements could be made based on the information available.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TPRLC 133 FP TYPE1 PPS SO 7.0
• Common Device Name: PROSTHESIS, HIPS
• 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: 23379451
• Report Number: 0001825034-2025-03332
• Device Sequence Number: 21132797
• Product Code: LZO
• UDI-Device Identifier: 00880304489653
• UDI-Public: (01)00880304489653(17)330905(10)J7589834
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-100070
• Device Lot Number: J7589834
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female