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	Emotional Changes (1831); Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (b)(4).Patient id: (b)(6).8/19/24: additional information received in in-box on 8/8/24.Attached email and revision op report.Updated aware date on tibial insert and added device information for femur, tibial tray, and patella based on new information received.Preoperative diagnosis indicated failed left total knee arthroplasty due to polyethylene wear.Postoperative diagnosis indicated left total knee arthroplasty due to polyethylene wear and early loosening.Indication for procedure: (b)(6) is a 79-year-old who underwent a prior total knee arthroplasty with a recalled prosthetic device.Due to concerns for early loosening and early polyethylene wear, the patient was offered revision total knee arthroplasty in its entirety.Intraoperative findings: significant osteolysis, early loosening of components and significant polyethylene wear of the patella component and tibial liner.Brief description of operative procedure: a parapatellar arthrotomy was performed and immediately upon making this, a large effusion was encountered.There were polyethylene fragments floating within the knee and polyethylene wear noted of the patellar component and tibial liner.Some early osteolysis was noted in the femur and tibia.Decision was made to proceed with full revision at this point.The patellar component was excised and resurfaced.The interface between the femoral component in the native femur was interrupted at the cement-implant interface and was therefore removed with minimal bone loss.The same technique was used to remove the tibial component with minimal bone loss.The patient was revised to a competitor¿s devices.No further issues or complication were reported.The patient was taken to recovery in stable condition.No additional information is available.Original description summary: it was reported via legal documentation that approximately 88 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, rehabilitation, pain and suffering, past and future cost of medical care, loss of earning capacity, and mental and emotional distress.No further issues or complications were reported.No additional information is available.The serial number (b)(6) is confirmed to be a part of recall number: z-0021-2022 02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm serial: (b)(6), 510k: k033883, udi: (b)(4), product code: jwh, x-ray: no, operative notes: yes.02-010-01-0250 - logic femoral ps cem left sz 5 serial: (b)(6), 510k: k033883, udi: (b)(4), product code: jwh.02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t serial: (b)(6), 510k: k101981, udi:(b)(4), product code: jwh.200-02-38 - three peg patella 38mm serial: (b)(6), 510k: k932690, udi: (b)(4), product code: jwh.
Additional Manufacturer Narrative
Concomitants: (b)(6), 02-010-01-0250 - logic femoral ps cem left sz 5.(b)(6), 02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm.(b)(6), 200-02-38 - three peg patella 38mm.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.
Additional Manufacturer Narrative
Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2024-03045, 1038671-2024-03046, and 1038671-2024-02886.

• 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: 20054105
• Report Number: 1038671-2024-03055
• Device Sequence Number: 12762077
• Product Code: JWH
• UDI-Device Identifier: 10885862004048
• UDI-Public: 10885862004048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2025
• Device Catalogue Number: 02-012-45-5040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2015
• 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; Hospitalization
• Patient Sex: Unknown