MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-72-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 7.5 years post the initial right total knee arthroplasty, the patient complained of knee swelling and pain and was diagnosed with wear of the tibial insert.The patient was revised and damage and wear were observed on the retrieved tibial insert, as well as the tibial tray.The surgeon decided that only the insert and tibial tray needed to be replaced with a truliant crc size 2 15 mm insert and tibial tray 2f/1t.A stem extention 14mm×40mm, 1/2 tibial augment size 1t-5mm (x2), 1/2 tibial augment rm/ll size 1t-10mm and 1/2 tibial augment rl/lm size 1t-10mm were also used.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10: 200-02-29 - three peg patella 29mm: 5384099.230-03-02 - optetrak asy,cr cemented femoral, sz 2: 5346293.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24815251
• Report Number: 1038671-2026-00400
• Device Sequence Number: 12268778
• Product Code: JWH
• UDI-Device Identifier: 10885862041210
• UDI-Public: 10885862041210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 12/31/2021
• Device Catalogue Number: 200-72-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 01/03/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female