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

Catalog Number	234-02-03
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Joint Laxity (4526); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices unknown.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 approximately 134 months after a left total knee replacement procedure, the underwent a revision procedure to address prosthesis wear, grooving and delamination of the patella resulting in a grossly loose tibial component as well as loosening of the femoral component.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
1038671-2024-02816 1038671-2024-02818 1038671-2024-04028 h6: corrected medical device problem code, component code, and type of investigation manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failure(s).However, the reported prosthesis wear, femoral loosening, and tibial loosening could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no product information, images, radiographs, or relevant clinical information was provided.
Event or Problem Description
It was reported via legal documentation that approximately 134 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, knee buckling and mechanical symptoms with the knee.Intraoperatively, the surgeon observed diffuse synovial proliferation with grey-colored staining to the synovial lining of the joint.The polyethylene liner was noted to have significant wear of the articular surface of the liner as well as grooving and delamination on the patellar button.It was also observed that the polyethylene liner was not locked into the baseplate, and the tibial component was significantly loose.Femoral component was noted to be debonded from the cement with and metaphyseal bone loss of the femur.The patellar component had erosive wear.The patient was revised to a competitor's construct.No medical or surgical intervention was reported.No additional information was provided.
Additional Manufacturer Narrative
A2, a3: added patient information.B:5 updated desc.Of event.B:7 added information.D4: corrected product information, d10 added information.G2: corrected report source.G5: added 501k.H4: added manufactured date.D10: (1620147) 204-04-32 - trapezoid tibial tray sz 3f/2t.(1690427 200-02-38 - three peg patella 38mm.(0919686) 204-23-13 - ps tibial inserts sz 3, 13mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d1/d2a/d2b, g3, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, 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, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failure(s).However, the reported prosthesis wear, femoral loosening, and tibial loosening could not be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no product information, images, radiographs, or relevant clinical information was 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,PS 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 ; 3523771140
• MDR Report Key: 19974155
• Report Number: 1038671-2024-02817
• Device Sequence Number: 7115425
• Product Code: JWH
• UDI-Device Identifier: 10885862063199
• UDI-Public: 10885862063199
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/06/2025

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: 03/01/2015
• Device Catalogue Number: 234-02-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 10/16/2024; Not provided; 01/03/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/18/2024; 12/11/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female