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

Catalog Number	02-012-35-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 75 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, swelling, stiffness, tissue damage, osteolysis, and synovitis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
No concomitants available.
Additional Manufacturer Narrative
New information: a2, a3, b5, d4 -catalog, serial, exp date, udi, g4- 510k, h4 corrected information: d4 - catalog #.
Event or Problem Description
Revision surgery operative notes were provided.Pre-op and post op diagnoses indicated periprosthetic osteolysis of internal prosthetic left knee joint.Patient was seen by their surgeon in the office with a failed left total knee replacement refractory to conservative management.Imaging was consistent with failed left knee arthroplasty.Description of procedure: a thorough synovectomy was performed and cultures were sent.The patella was dislocated and the knee was flexed.At this point we began removal of our implants.Using a combination of a small saw and osteotomes, the femoral implant was removed with minimal bone loss.Our attention was then turned to the tibia.Once again, using the small saw and osteotomes, the tibia was removed with minimal bone loss.The patient was revised to a competitor¿s devices with no complications.The patient was transferred to the recovery room in stable condition.No additional information is available.

• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19472203
• Report Number: 1038671-2024-01769
• Device Sequence Number: 11654093
• Product Code: JWH
• UDI-Device Identifier: 10885862001894
• UDI-Public: 10885862001894
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 06/26/2023
• Device Catalogue Number: 02-012-35-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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: 64 YR
• Patient Sex: Male