MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 MP SP T1 PPS HO 8X101; PROSTHESIS, HIP

Catalog Number	51-109080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced left anterior hip pain approximately 5 years and 10 months post-implantation.Imaging did not demonstrate any prosthetic issues, and medication was prescribed.No fall or trauma were reported.The patient remained in the study with all initial components retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - stem.D10: cat# 650-1057 lot# 2904517 cer bioloxd option hd 36mm.Cat# 650-1064 lot# 2900787 cer option type 1 tpr sleve -6.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: 5 years follow up visit participates in mild activities regularly, some mild difficulty with adls ae entered patient reported anterior left hip pain, 8/10 intensity.Pain medication prescribed- tramadol.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 for trends.

• Brand Name: TLOC 133 MP SP T1 PPS HO 8X101
• 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: 24199032
• Report Number: 0001825034-2026-00238
• Device Sequence Number: 5495242
• Product Code: JDI
• UDI-Device Identifier: 00880304513037
• UDI-Public: (01)00880304513037(17)250722(10)3590303
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/22/2025
• Device Catalogue Number: 51-109080
• Device Lot Number: 3590303
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2015
• 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: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: White