MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3015
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 2025335, 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t, 2184803, 200-02-32 - three peg patella 32mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.2189770, 02-012-35-3013 - logic tibia ps mod insrt sz 3 13mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.2191764, 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t, 2195603, 02-010-01-0330 - logic femoral ps cem right sz 3, 2223753 ,200-02-32 - three peg patella 32mm.
Event or Problem Description
It was reported that this 63 y/o female patient's right knee was revised approximately 12 years post op initial surgery.Patient complained of pain.Loose femur and recalled poly.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported in case-(b)(4) was likely the result of an insufficient bond between the femoral component and bone which led to aseptic (non-infected) femoral loosening and pain after 12 years of implantation.However, potential contributions from prosthesis wear, and/or patient-related conditions to the reported event cannot be confirmed as the devices were not available for evaluation and limited information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of an insufficient bond between the femoral component and bone which led to aseptic (non-infected) femoral loosening and pain after 12 years of implantation.However, potential contributions from prosthesis wear, and/or patient-related conditions to the reported event cannot be confirmed as the devices were not available for evaluation and limited information was 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 PS MOD INSRT SZ 3 15MM
• 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
• MDR Report Key: 19296357
• Report Number: 1038671-2024-01189
• Device Sequence Number: 12266012
• Product Code: JWH
• UDI-Device Identifier: 10885862001832
• UDI-Public: 10885862001832
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2019
• Device Catalogue Number: 02-012-35-3015
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 12/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 12/20/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2011
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female