MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): 6543877 - 02-012-45-3030 - lgc tibial fit tray cem sz 3f/3t.6631122 - 200-02-32 - three peg patella 32mm.6500615 - 204-34-04 - fluted stem extension 40l x 14 mm.6418635 - 204-70-00 - tibial stem ext.Screw.
Event or Problem Description
It was reported that the 66 y/o female patient's left knee was revised approximately 3 years post op.Patient had fallen and was having pain with knee.The 11mm size 3 liner and 32mm patella were removed and while inspecting the prosthesis the femoral component had become loose.The surgeon recemented a new femoral component and implanted an 11mm psc size 3 implant and 35mm patella.Patient was last known to be in stable condition following the event.Product not returning - discarded at the hospital.
Additional Manufacturer Narrative
H3: the revision reported was likely due to prosthesis wear that resulted from malalignment between the femoral and tibial components and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The reported femoral loosening may have been a result of the reported fall, but this cannot be confirmed.Additionally, a contributing factor to the wear of the tibial insert may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, the extent and likely cause of the prosthesis wear and femoral loosening could not be confirmed as the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19940398
• Report Number: 1038671-2024-02745
• Device Sequence Number: 12615958
• Product Code: JWH
• UDI-Device Identifier: 10885862173560
• UDI-Public: 10885862173560
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110547
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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 Expiration Date: 10/06/2023
• Device Catalogue Number: 02-012-44-3011
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female