MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cellulitis (1768); Cyst(s) (1800); Synovitis (2094); Implant Pain (4561); Insufficient Information (4580); Medical device site infection (4845)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 5743276 02-010-04-0230 - logic cr femoral por, left, sz 3.6289327 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.6757428 201-78-15 - holding pin mini sharp point 4 pk.6557836 201-78-81 - 3 trocar, mod.Hex 2pk.S103825 521-78-23 - threaded pin size 2.3 collared.S125864 521-78-23 - threaded pin size 2.3 collared.S007882 521-78-32 - threaded pin size 3.0 collarless.09000320004 a10012 - gps implant kit v2.
Event or Problem Description
It was reported that approximately 42 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear of the tibial insert and patellar component.No further issues or complications were reported.Patient was last known to be in stable condition following the event.Device images and x-rays were provided.The explanted devices were disposed of by the hospital.No additional information is available.
Additional Manufacturer Narrative
Additional information: h3: the revision reported was likely the result of infection, component loosening, and prosthesis wear.However, the reported wear of the patella could not be confirmed.The reported cellulitis may have led to the infection of the patient¿s knee, resulting in loosening and subsequent third body wear; however, the sequence of events and the likely cause of the infection, loosening, and insert wear could not be confirmed as the devices were not returned for evaluation.H6: health effect-clinical code, component code, investigation codes.
Event or Problem Description
Everything was revised.Legal notification received.Clinical details: initial left tkr on (b)(6) 2021.Known poly oxidation risk, popliteal cyst, synovitis.Had significant episode of cellulitis in 2023 requiring intravenous antibiotics.Possible source of inoculation.Clinically infected tkr.Elevated crp, warm swollen, painful and positive bone scan.

• Brand Name: OPTETRAK LOGIC
• 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 66 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19651792
• Report Number: 1038671-2024-02245
• Device Sequence Number: 20489206
• Product Code: JWH
• UDI-Device Identifier: 10885862230409
• UDI-Public: 10885862230409
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2024

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 Catalogue Number: 02-012-51-3009
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female