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

Catalog Number	02-012-47-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 46 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.The liner was replaced.There were no surgical delays or device breakages during the procedure.No further issues or complications were reported.The patient was last known to be in stable condition following the event.The explanted device is not available for return as it was disposed of by the customer.No x-rays or device images were able to be obtained.No additional information is available.
Additional Manufacturer Narrative
Patient's rt knee revision on 4/10/2024 reported under 1038671-2020-00545 d10: concomitant devices: 5935891 02-010-04-0250 - logic cr femoral por, left, sz 5.4049161 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.5836894 200-02-38 - three peg patella 38mm.6298319 201-78-15 - holding pin mini sharp point 4 pk.6005587 201-78-81 - 3 trocar, mod.Hex 2pk.S018345 521-78-23 - threaded pin size 2.3 collared.S049106 521-78-23 - threaded pin size 2.3 collared.S064307 521-78-23 - threaded pin size 2.3 collared.01000320008 a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Correction: patient's rt knee revision on (b)(6) 2024 reported under 1038671-2020-00545 should be "patient's left knee revision on (b)(6) 2020." additional information: h3 - according to the information provided, the patient underwent a left total knee replacement surgery in (b)(6) 2020.Approximately 2 weeks later, on (b)(6) 2020, the patient underwent a revision surgery.The liner was replaced.Approximately 3 years and 10 months later, on (b)(6) 2024, the patient underwent a second revision surgery due to prosthesis wear.Components were not returned for evaluation and no images or radiographs were provided.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.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, radiographs, and relevant clinical information were not provided.H6 - component code and investigation codes.

• 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19645140
• Report Number: 1038671-2024-02226
• Device Sequence Number: 6578745
• Product Code: JWH
• UDI-Device Identifier: 10885862174543
• UDI-Public: 10885862174543
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 06/18/2026
• Device Catalogue Number: 02-012-47-5009
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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: 56 YR
• Patient Sex: Male