MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 5F / 4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-5040
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 1740459 02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm 2914040 02-010-01-0250 - logic femoral ps cem left sz 5 3550289 200-02-32 - three peg patella 32mm the device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ united states (mdl no.3044) related case for revision of rk documented on (b)(4).It was reported that approximately 119 months after a left total knee replacement procedure, the patient underwent a revision procedure to address loosening, instability, recurrent effusions, extensive synovitis, osteolysis, aseptic loosening of femur and tibia, and grossly loose patella; delaminated polyethylene debris.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Correction: please disregard initial report as it was determined this product was logged in error and is not reportable.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 5F / 4T
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20052762
• Report Number: 1038671-2024-03052
• Device Sequence Number: 8044385
• Product Code: JWH
• UDI-Device Identifier: 10885862004048
• UDI-Public: 10885862004048
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 11/20/2023
• Device Catalogue Number: 02-012-45-5040
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2013
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Sex: Male