MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	230-02-03
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); No Information (3190)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: tibial insert, size 3, 11mm (cn; 200-63-11, sn; (b)(4)); tibial tray, size 3f/2t (cn; 204-04-32; sn: (b)(4)); three peg patella (cn: 200-02-35, sn: (b)(4)).
Event or Problem Description
As reported, approximately 9 yrs postoperative total knee arthroplasty was performed on this (b)(6) y/o female patient dr.(b)(6) determined that the component had failed.Dr.Newman opened the joint in standard fashion.He decided to take everything out and implant a stryker revision knee.He then closed the joint in standard fashion.The patient left the or in stable condition.Hospital did not release implants for return to exactech.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that upon review of all available information, the reason for revision reported in this event was not provided but was likely the result of wear, loosening, infection, fracture, instability, or patient-related factors.Section (d10) concomitant devices: tibial insert, size 3, 11mm (cn; 200-63-11, sn; (b)(6)).Tibial tray, size 3f/2t (cn; 204-04-32; sn: (b)(6)).Three peg patella (cn: 200-02-35, sn: (b)(6)).
Additional Manufacturer Narrative
Corrected b1, b2 updated b5 corrected h6: clinical codes, medical device problem code, component code and investigation codes.
Event or Problem Description
It was reported that approximately 101 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, increased pain and mechanical symptoms.Initial surgery and revision surgery operative notes were provided.Post operative diagnosis noted wear, loosening and fracture of the polyethylene liner and loosening of the femoral component.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, disassembly, fracture, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3,
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 9774892
• Report Number: 1038671-2020-00233
• Device Sequence Number: 1367793
• Product Code: JWH
• UDI-Device Identifier: 10885862061683
• UDI-Public: 10885862061683
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/05/2025

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: 08/01/2016
• Device Model Number: 230-02-03
• Device Catalogue Number: 230-02-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 08/27/2020; Not provided; 06/04/2025
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 09/24/2020; 12/09/2024; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2011
• 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.; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female