MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN REV TIB FIX NP SZ E L; PROSTHESIS, KNEE

Catalog Number	42542007101
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)( d10: 42504606601, psn rev fem cmt ccr std sz 9l, lot 66807668 42560007514, psn rev str smth stem 14x75, lot 66892680 42560007514, psn rev str smth stem 14x75, lot 66884399 42512800714, articular surface fixed bearing constrained condylar knee (cck) left 14 mm height use, lot 65920191 g2: event occurred in australia the reported event was unable to be confirmed.Visual examination of the provided pictures identified explanted devices covered in bio debris.No product was returned, therefore no further evaluations could be made.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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
It was reported that patient underwent a first stage revision of competitor products, and was implanted with zimmer biomet devices.Subsequently, the patient was revised approximately 4 months post implantation due to loosening.Attempts have been made and no additional information is available.

• Brand Name: PSN REV TIB FIX NP SZ E L
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22709132
• Report Number: 0001822565-2025-02785
• Device Sequence Number: 9759723
• Product Code: JWH
• UDI-Device Identifier: 00889024562790
• UDI-Public: (01)00889024562790(17)321104(10)65579318
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• 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
• Report Date (Section B): 08/04/2025

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: Lay User/Patient
• Device Catalogue Number: 42542007101
• Device Lot Number: 65579318
• 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: 07/14/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown