MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-010-01-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal department, approximately 4 years post op the initial right tka, this female patient was revised due to implant loosening and significant synovitis.Patient had been complaining of mechanical complications and chronic pain.During revision surgery, the surgeon noted that there was "obvious implant loosening" and that there was "extensive synovitis and obvious shards of polyethylene visible".The subsequent post-operative diagnosis confirmed that the plaintiff's right total knee arthroplasty failed due to significant loosening, which is related to the failure in the polyethylene.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-012-45-3535, (b)(4): lgc tibial fit tray cem sz 3.5f / 3.5t, 200-02-35, (b)(4): three peg patella 35mm, 02-012-35-3513, (b)(4): logic tibia ps mod insrt sz 3.5 13mm.
Additional Manufacturer Narrative
H6: investigation results: the revision reported may have been the result of loosening and prosthesis wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the implant and the bone.The tibial insert wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years, which may have contributed to the reported wear.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM
• 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: 15029418
• Report Number: 1038671-2022-00794
• Device Sequence Number: 6178134
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 05/04/2021
• Device Model Number: 02-010-01-0335
• Device Catalogue Number: 02-010-01-0335
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female