MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-23-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 200-02-32 - three peg patella 32mm: (b)(6).200-04-33 - cemented finned tib.Tra sz 3f/3t: (b)(6).201-46-10 - holding pin headless 3" (4 pk): (b)(6).230-03-03 - optetrak asy, cr cemented femoral, sz 3: (b)(6).620-00-02 - platelet rich plasma kit with spray tips: (b)(6).620-11-02 - accelerate conc.Sys rep by 620-12-02: (b)(6).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.
Event or Problem Description
It was reported that the patient underwent a knee replacement procedure.Subsequently, the patient required a revision surgery due to pain and osteolysis.The patient tolerated the procedures well with no reported complications.No further information is available.

• Brand Name: CR TIBIAL INSERT SZ3, 11MM
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: katy priest ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25225325
• Report Number: 1038671-2026-00627
• Device Sequence Number: 9810821
• Product Code: JWH
• UDI-Device Identifier: 10885862040251
• UDI-Public: 10885862040251
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 06/17/2017
• Device Catalogue Number: 200-23-11
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 06/18/2009
• 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: Hospitalization
• Patient Sex: Unknown