MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	230-03-02
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2024-02642.Manufacturer narrative: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and 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 and 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 135 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, polyethylene wear, osteolysis, and aseptic loosening.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 following sections were updated: d2a, d2b, g3, h6.The following sections were corrected:, d1, d4, h4, 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 and 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 and 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.
Additional Manufacturer Narrative
A1-2: added patient age and d.O.B.B5: updated description of event-additional information received from op report.D4: corrected catalogue, serial numbers, expiration date and udi #.D10 added "see h11".G3: corrected date received by manufacturer to 09-feb-2024.G5: corrected 501k.H6: added clinical codes 4530,2094,1994.Corrected impact code to 4629.D10: (b)(6) 200-62-13 - cr tibial insert sz 2, 13mm, slope +.(b)(6) 204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t.(b)(6) 200-02-35 - three peg patella 35mm.
Event or Problem Description
It was reported via legal documentation that approximately 135 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear polyethylene wear, osteolysis, aseptic loosening.Operative report notes the knee appeared to be ligamentous grossly loose as well as fairly significant polyethylene liner wear that i suspected had already worn completely through.It was obviously notable initially upon entering the joint that she had severe blackened synovitis due to the metal-on-metal articulation and complete polyethylene failure and catastrophic dislodgement.There was notable bone loss both on the medial and lateral femoral condyle that seemed to be uncontained.The tibial had a central defect as well as an uncontained defect on the lateral condyle.The patella appeared to be grossly intact with good tracking and was retained.The patient was revised to a competitor¿s devices.There were no apparent complications and no deviations in surgical plan.The patient was last known to be in stable condition following the procedure.No additional information is available.

• Brand Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20383118
• Report Number: 1038671-2024-03834
• Device Sequence Number: 6566981
• Product Code: JWH
• UDI-Device Identifier: 10885862061744
• UDI-Public: 10885862061744
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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: 10/08/2016
• Device Catalogue Number: 230-03-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2024
• Supplement Date Received by Manufacturer: 02/09/2024; 12/12/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/21/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female