MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 11MM; 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	Cyst(s) (1800); Discomfort (2330); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2023-00778.D10: concomitant devices: (b)(6), 02-012-35-4011 - logic tibia ps mod insrt sz 4 11mm; (b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t; (b)(6), 200-02-32 - three peg patella 32mm.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.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.
Event or Problem Description
It was reported via a legal notification that a 67 yo male patient, initial left knee implanted, underwent a revision total knee arthroplasty procedure approximately 11 years post the initial procedure.The patient was having swelling and discomfort with activity.Preoperative diagnosis indicated a failed total knee arthroplasty with effusion, with concern for poly wear.Risks, complications, and alternatives were discussed, the patient agreed to the planned procedure.Incision was made.The patella was evaluated and found to have minimal if any wear.The edge of the patella was completely pristine with no evidence of loosening or debridement.There was no evidence of loosening or rocking of the proximal tibia.Attention turned to the femur.Loose femoral component with cystic formation in the medial compartment noted.Revision total knee arthroplasty, femur with a new 13 mm insert conducted.The patient was awakened and taken to recovery in good condition.No device returns anticipated due to this being a legal case.No further information.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 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 INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21028533
• Report Number: 1038671-2024-05029
• Device Sequence Number: 14508917
• 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: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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
• Device Expiration Date: 06/09/2018
• 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: 03/23/2023
• Initial Report FDA Received Date: 12/27/2024
• Date Device Manufactured: 06/09/2010
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown