MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT PSC, SIZE 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-4015
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Report 2 of 2 for this event: it was reported a patient underwent a left total knee arthroplasty.Subsequently, five (5) years, six (6) months later, the patient experienced left knee instability and significant pain.As a result, the patient underwent a left knee revision due to loosening and prosthesis wear.It was reported that intraoperatively the surgeon observed significant loosening of the femoral component, subsidence, polyethylene component wear, synovitis, and osteolysis.No further complications were reported.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated report: 1038671-2022-00844.The revision reported in this event was likely the result of a combination of aseptic loosening between the femoral component and the bone and prosthesis wear.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contributions of loosening and prosthesis wear to the sequence of events and potential contributions from implant positioning and/or patient-related factors to the sequence of events cannot be confirmed as the devices are not available for evaluation and limited information was available at the time of evaluation.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique exactech has recently discovered that a bag used in the packaging of our polyethylene inserts has been produced outside of our quality specifications.The use of these non-conforming bags may enable increased oxygen diffusion to the uhmwpe (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with bags that conform to exactech¿s specifications.For inserts with greater than five years of shelf life, increased oxidation of the inserts can lead to premature polyethylene wear resulting in a revision surgery.However, while the insert was packaged in a non-conforming bag, it was on the shelf for only slightly more than a year before being implanted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TIBIAL INSERT PSC, SIZE 4, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24009355
• Report Number: 1038671-2026-00023
• Device Sequence Number: 13073962
• Product Code: JWH
• UDI-Device Identifier: 10885862173669
• UDI-Public: 10885862173669
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 02-012-44-4015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 12/12/2013
• 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