MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Catalog Number	51-108080
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unequal Limb Length (4534); Bursitis (4832); High metal ion levels (4847); Joint effusion (4849)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, it was reported that patient is experiencing problems due to metallosis and high chromium levels.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - stem.G2: foreign: canada.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: a1; a2; a3; b3; b5; b6; b7; d1; d2; e1; e2; e3; d4; g2; g3; g4; h2; h6.
Event or Problem Description
It was reported that the patient underwent a right total hip arthroplasty.The patient subsequently developed complications associated with metallosis and elevated chromium levels and was revised approximately 3 years later.During the revision, a substantial amount of gray-colored tissue, pseudotumor formation, and metallosis deposits were observed.The femoral stem, acetabular shell, and liner were found to be stable and were therefore retained.The femoral head was revised without complications.Attempts have been made and no further information has been provided.
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 records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: findings consistent with adverse reaction to metal debris or trunnionosis.Lab results: chromium 24 (high), cobalt 120 (high).Revision right total hip arthroplasty.Right hip metalosis/trunnionosis with elevated metal ions and abductor repair.Significant amount of gray-colored tissue, significant amount of pseudotumor and metalosis deposits.Micro damage to the trunnion 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.
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: a4; b6; b7; d4; g3; h2; h6.
Event or Problem Description
No further information at the time of this report.

• Brand Name: TPRLC 133 MP T1 PPS SO 8X101MM
• Common Device Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
• 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: 23581595
• Report Number: 0001825034-2025-03673
• Device Sequence Number: 9533141
• Product Code: KWA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/29/2026

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 Catalogue Number: 51-108080
• Device Lot Number: 6800519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 02/19/2026; 04/15/2026; 09/23/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/04/2026; 02/20/2026; 04/27/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2020
• 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: Female
• Patient Weight: 110 LB