MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	230-03-05
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Osteolysis (2377); Implant Pain (4561); Joint effusion (4849)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 200-02-38 - three peg patella 38mm (b)(6) 200-04-55 - cemented finned tib.Tra sz 5f/5t 1(b)(6) 200-25-11 - cr tibial insert sz 5, 11mm (b)(6) the device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that a patient had a right knee arthroplasty on (b)(6) 2012 and then approximately 8 years and 6 months later on (b)(6) 2020 all devices were surgically revised for polyethylene wear with osteolysis and loose femoral/tibial/patellar button.There is no other information available.No images were provided.
Additional Manufacturer Narrative
A2-3: added patient age, d.O.B and gender b5: updated description event to reflect operative note findings added clinical codes: 1932, 4849, 4561.Corrected component code to 4755.
Event or Problem Description
It was reported via legal documentation 8 years and 6 months after a right total knee arthroplasty a patient developed worsening right knee pain and swelling and was surgically revised.Operative notes indicate negative for acute inflammation and evidence of chronic inflammation intraoperative findings include polyethylene wear with osteolysis and loose femoral, tibial and patellar button, as well as femoral condyle bone loss.There were no complications with revision and patient was transferred to pacu in stable condition there is no other information available.No images were provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h4, h6.Mdr section codes updated/corrected: b, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, tibial loosening, and patellar 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 5
• 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 ; 3523771140
• MDR Report Key: 20258077
• Report Number: 1038671-2024-03628
• Device Sequence Number: 8014191
• Product Code: JWH
• UDI-Device Identifier: 10885862061775
• UDI-Public: 10885862061775
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2025

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: 01/22/2015
• Device Catalogue Number: 230-03-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided; 08/20/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/25/2024; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2010
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male