MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-3535
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5.5 years post op the initial left tka, this 70 y/o male patient was revised due to a loose femur.Patient was complaining of pain.Pictures show scar tissue/synovial fluid from the poly and loose femur.Patient was last known to be in stable condition following the event.No other patient information/medical history.Device is not returning, hospital will not release.
Additional Manufacturer Narrative
Pending evaluation: concomitant medical device(s): (b)(4), 02-012-44-3509 - logic tibia implant psc insert, sz 3.5, 9mm; (b)(4), 02-010-01-0235 - logic femoral ps cem left sz 3.5; (b)(4), 201-78-81 - 3" trocar, mod.Hex 2pk; (b)(4), 201-78-81 - 3" trocar, mod.Hex 2pk; (b)(4), 200-02-35 - three peg patella 35mm.
Additional Manufacturer Narrative
Section h10: h3: the revision reported may have been the result of loosening, osteolysis, and prosthesis wear as stated in the legal documentation and experience report.The aseptic (non-infected) loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.The loosening likely led to instability and an increase in cement and bone particles in the joint space and resulted in polyethylene wear and osteolysis.However, this cannot be confirmed as the device(s) were not returned for evaluation and pre-revision radiographs and operative notes were not provided.Section h11: the following sections have corrected information: h6: component code: 734, bearings, 4755, part/component/sub-assembly term not applicable.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16207103
• Report Number: 1038671-2023-00046
• Device Sequence Number: 20197283
• Product Code: JWH
• UDI-Device Identifier: 10885862003997
• UDI-Public: 10885862003997
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2025
• Device Catalogue Number: 02-012-45-3535
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male