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

Catalog Number	02-012-45-4040
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651); Aseptic loosening (4883)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0240 - logic femoral ps cem left sz 4, (b)(6), 02-012-44-4009 - logic tibia implant psc insert, sz 4, 9mm, (b)(6), 200-02-35 - three peg patella 35mm, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6), 620-00-02 - platelet rich plasma kit with spray tips bone marrow 60ml, (b)(6), sa-3615 - cannula style app tip, h10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-00951, 1038671-2026-00419 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have resulted from loosening and tibial insert wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral and tibial components and the bone.The tibial insert wear may have been due to malalignment between the implants, third body wear, patient related conditions, instability, or any combination of these possibilities.Additionally, prosthesis wear was not reported in the revision operative report.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty on the left side.Subsequently, the patient experienced pain, bone scans suggested loosening, no signs of infection.As a result, approximately two years and seven months post-surgery, the patient underwent a revision.The revision operative report stated, there was a ¿little bit of overgrowth of soft tissue over the patella, but otherwise in good condition¿there were no signs of infection¿ we then began to look at the implants and probing around the femur.The bone was extremely soft on the lateral aspect where he was 17 and after further investigation found that there was some loosening on this femoral implant.¿ the patient¿s postoperative diagnosis was ¿loosening of tibial and femoral components due to osteopenic bone.¿ wear was not reported for the tibial insert in the operative report.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available.This is report 3 of 3 for this event/patient.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 4F / 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24873548
• Report Number: 1038671-2026-00420
• Device Sequence Number: 13266742
• Product Code: JWH
• UDI-Device Identifier: 10885862004024
• UDI-Public: 10885862004024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: 03/31/2024
• Device Catalogue Number: 02-012-45-4040
• 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: 08/02/2022
• Initial Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 04/03/2014
• 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 Age: 46 YR
• Patient Sex: Male