MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-44-2513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had left tka (b)(6) 2015 due to severe osteoarthritis.They underwent left knee revision (b)(6) 2022, approximately 6 years10 months after their initial procedure.Postoperative diagnosis: implant wear with osteolysis, and loosening.The surgeon noted that the patient had a large amount of foreign body reaction tissue throughout the entire knee joint.There was loosening of the femoral component, and the insert was noted to have a fair amount of wear.According to the surgeon, "a good deal of foreign body reaction tissue had occurred with erosion of bone, particularly on the posterior section of the femoral component, which allowed the component to work loose." there is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 4045505 02-010-01-0225 - logic femoral ps cem left sz 2.5.4068828 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.4118715 200-02-29 - three peg patella 29mm.
Additional Manufacturer Narrative
Recall number: z-0021-2022.1038671-2024-05110 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-05110 d10: concomitants: (b)(6) 02-010-01-0225 - logic femoral ps cem left sz 2.5.(b)(6) 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.(b)(6) 200-02-29 - three peg patella 29mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening 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 and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 16934758
• Report Number: 1038671-2023-00996
• Device Sequence Number: 12266408
• Product Code: JWH
• UDI-Device Identifier: 10885862173539
• UDI-Public: 10885862173539
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: 03/06/2020
• Device Model Number: 02-012-44-2513
• Device Catalogue Number: 02-012-44-2513
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2012
• 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 H10; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female