MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 2, 13MM
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Unstable (1667)
Health Effect - Clinical Codes	Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 79 yo male, initial right knee implanted on (b)(6) 2002, had loosening of joint space over time, and was revised on (b)(6) 2022, approximately 20 years 4 months post the initial procedure.Pt had a 13mm poly implanted.Only sizes 13mm, 15mm, and 30mm were available from exactech.15mm was too loose and the 30mm was just too big.Surgeon had to pull everything and revised using competitors devices.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Concomitants: 204-01-02, 7329981 - ps cemented femoral sz 2; 200-04-23, bdfwn - cemented finned tib.Tra sz 2f/3t; 200-02-35, 0329818 - three peg patella 35mm.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision for instability cannot be conclusively determined; however it is most likely related to patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (delete from initial report-suspect device unknown), g4 (remove from initial report - 501k unknown) h4 (remove erroneous date from initial report), h6 clinical code, device problem code, component code, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: OPTETRAK KNEE COMPONENTS
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 15540527
• Report Number: 1038671-2022-01237
• Device Sequence Number: 6972285
• Product Code: JWH
• UDI-Device Identifier: 10885862048240
• UDI-Public: 10885862048240
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• 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): 10/29/2025

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: 11/08/2006
• Device Model Number: PS TIBIAL INSERTS SZ 2, 13MM
• Device Catalogue Number: 204-22-13
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2001
• 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 H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male