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

Model Number	204-25-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had left knee replacement surgery on (b)(6)2009.He had left knee revision on (b)(6)2023, approximately 13 years 5 months after their initial implantation.He has developed progressive pain and debilitation related to his left knee.His x-rays showed what appeared to be loosening of the femoral component with debonding of the anterior flange with the cement mantle.The patellar component was well fixed however was severely worn and therefore, replaced.The femoral component had significant debonding of the cement prosthetic interface under the anterior flange and was easily removed.There also appeared to be loosening of the tibial component as it was removed from its cement mantle relatively easily.The polyethylene liner had minimal wear except for on the anterior portion of the tibial spine.There was synovial hypertrophy consistent with component loosening.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: (b)(6), 200-02-38 - three peg patella 38mm; (b)(6), 204-04-55 - trapezoid tibial tray sz 5f/5t; (b)(6), 204-34-02 - fluted stem extension 25l x 14 mm; (b)(6), 204-70-00 - tibial stem ext.Screw; (b)(6), 234-02-05 - optetrak asy,ps cemented femoral, sz 5.
Additional Manufacturer Narrative
B1: updated.B2: updated.D1: updated.D4: added catalog number, expiration date, serial number, and udi.G3: updated 510k number.H4: added device manufacture date.H6: corrected health effect clinical code, component code, type of investigation, investigation findings, and investigation conclusions.The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening, prosthesis wear, a failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface and the reported pain, and/or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.

• Brand Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 5,
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: kate jacobson ; 3523782617
• MDR Report Key: 16933641
• Report Number: 1038671-2023-00995
• Device Sequence Number: 7451231
• Product Code: JWH
• UDI-Device Identifier: 10885862063212
• UDI-Public: 10885862063212
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Device Expiration Date: 01/29/2014
• Device Model Number: 204-25-13
• Device Catalogue Number: 234-02-05
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2009
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male