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); Insufficient Information (4580)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) 200-03-32 - one peg patella 32mm, (b)(6) 200-04-33 - cemented finned tib.Tra sz 3f/3t, (b)(6) 230-02-03 - optetrak asy, cr cemented femoral, sz 3.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported a 67 yo female patient underwent a left knee revision procedure approximately 12 years 6 months post the initial procedure.The surgeon indicated the patient required a poly swap.On the day of surgery, upon explantation, the cr poly was removed and found to have medial wear and delamination.The patient has bilateral cr knees and both knees have liners and patellas on the recall list.Doctor was informed and patella was also removed.Crc liner was reimplanted along with patella.There were no surgical delays or device breakages during the event.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available as the hospital will not release them.Device images were provided.No further information.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, inclusion of the polyethylene in the packaging recall or any combination of these possibilities.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.D1: corrected.H6: corrected health effect and investigation clinical codes.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22014981
• Report Number: 1038671-2025-02052
• Device Sequence Number: 7837271
• Product Code: JWH
• UDI-Device Identifier: 10885862040251
• UDI-Public: 10885862040251
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: Health Professional
• Device Expiration Date: 08/02/2016
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2008
• 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
• Patient Age: 67 YR
• Patient Sex: Female