MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint effusion (4849)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case (b)(6) rk rev.As reported via legal documentation: pre & post operative diagnosis: right total knee arthroplasty with polyethylene failure.Indications for procedure: the patient is a 79-year-old female with history of right total knee arthroplasty, which initially performed well and then resultantly starting to have pain and effusion.A workup of the fusion with esr and crp was performed, which was negative for infection and also a ct scan to evaluate for osteolysis and loosening, which was no significant of either.Medial part of the polyethylene recall within the fusion that is constant without otherwise any other etiology.The patient did also have some asymmetry on the polyethylene on the standing x-ray.Because of all these things, the need for polyethylene exchange and associated synovectomy was expressed.From procedure in detail: during medial parapatellar arthrotomy, a large affusion with no purulence or metallosis could quickly be seen.Upon removal of the polyethylene, it was stated "we could easily see destruction of the medial compartment with delamination and pitting and discoloration or fracture of the posterior lip of the polyethylene." inspection of the tibial tray did not yield any metallic falling off of it.Patient transferred to the recovery room in stable condition.No complications occurred throughout the case.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.No additional information available.(b)(4), 02-012-48-1509 - logic cr tib insert slope +, sz 1.5, 9 mm.Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k111400.Concomitants: 4695534, 02-010-03-0315 - logic cr femoral cem, right, sz 1.5; 5602889, 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t; 5545398, 200-02-29 - three peg patella 29mm.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 4695534, 02-010-03-0315 - logic cr femoral cem, right, sz 1.5; 5602889, 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t; 5545398, 200-02-29 - three peg patella 29mm.
Additional Manufacturer Narrative
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.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and fracture or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
• 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 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 16765505
• Report Number: 1038671-2023-00740
• Device Sequence Number: 2920742
• Product Code: JWH
• UDI-Device Identifier: 10885862144379
• UDI-Public: 10885862144379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 08/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 02-012-48-1509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 01/01/2025
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female