MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	CR TIBIAL INSERT SZ 2, 15MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely due to patient related conditions.
Event or Problem Description
It was reported that a female patient had a left knee implanted in 2002, and was revised on an unknown date.The patient was having pain, so the doctor took out the optetrak cr size 2 15 mm poly and put in a truliant cr size 2 17mm poly.The only information the representative is able to provide is that the case was in 2022 and that there is no serial numbers for the devices available.There were no reported issues during the surgical revision procedure.The patient was last known to be in stable condition.The device is not available for return, the hospital kept it.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3 (remove erroneously entered date on initial report -date of event is an unknown date in 2022), d1, d6b (remove erroneously entered date from initial report - explant is an unknown date of unknown year), h6 clinical code, device problem code, component code, type of investigation, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: CR TIBIAL INSERT SZ 2, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: kate jacobson ; 3523771140
• MDR Report Key: 15789813
• Report Number: 1038671-2022-01459
• Device Sequence Number: 5623118
• Product Code: JWH
• UDI-Device Identifier: 10885862040220
• UDI-Public: 10885862040220
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2022
• 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): 02/02/2026

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 Model Number: CR TIBIAL INSERT SZ 2, 15MM
• Device Catalogue Number: 200-22-15
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Sex: Female