MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	234-03-04
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Joint Laxity (4526)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1312822 204-24-11 - ps tibial inserts sz 4, 11mm 2955632 200-02-32 - three peg patella 32mm 3003748 204-04-44 - trapezoid tibial tray sz 4f/4t 5121025 204-24-09 - ps tibial inserts sz 4, 9mm the product associated with the reported event 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 that approximately 73 months after a total right knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, loosening, instability, and osteolysis.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
H10.Mfr#s for this event- 1038671-2023-00347.Report 1 of 4, 1038671-2024-01762.Report 3 of 4, 1038671-2024-01764.Report 4 of 4.Additional information added.Report 2 of 4.H3.The revision reported may have been the result of loosening of the femoral component and tibial tray, wear of the patella and tibial insert, osteolysis, and joint instability.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the implants and the bones.The cause and extent of the instability and loosening cannot be determined because the revised components were not returned for evaluation and no images or radiographs were provided.Exactech complaint history from 01/01/2008 ¿ 04/01/2024 was used to calculate a complaint occurrence rate for each alleged failure, respectively, of <(b)(4).This is considered ¿very low¿.This event does not this does not appear to be design-related.A review of the risk management report and risk assessment and controls report was conducted to ensure the risks were included and the occurrences are below the threshold.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4,
• 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: 19471231
• Report Number: 1038671-2024-01761
• Device Sequence Number: 17998026
• Product Code: JWH
• UDI-Device Identifier: 10885862063274
• UDI-Public: 10885862063274
• Combination Product (Y/N): N
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 04/26/2015
• Device Catalogue Number: 234-03-04
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2010
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male