MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, the 58-year-old patient had a left tka on (b)(6) 2015.On (b)(6) 2021, patient presented polyethylene wear without evidence of osteolysis.On (b)(6) 2021, the patient underwent arthroscopy, biopsy and debridement of right knee due to pain and pulling, x-ray shows excessive medial poly wear that is reported on (b)(4).The patient then underwent right total knee replacement revision surgery on (b)(6) 2023 as a result of this event and the outcome is considered to be resolved.The case report form indicates that this event is definitely not related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 02-010-01-0240 - logic femoral ps cem left sz 4.02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.200-02-38 - three peg patella 38mm.(h3) pending evaluation.
Additional Manufacturer Narrative
This case is a duplicate report of 1038671-2023-00563 and 1038671-2024-03343.
Additional Manufacturer Narrative
Upon further review of the information associated with this patient and their event history, it was identified that this case record had been initiated erroneously.No allegation was made against the patient¿s left knee, rather the information received was in context to the contralateral knee (right side) as having experienced adverse issues that required medical/surgical action.The contralateral side was previously reported to the regulatory authority under (b)(4).No further information was received to indicate that the patient experienced any adverse effects associated with their left total knee replacement.As a result, this case record has been determined to be non-reportable.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19084963
• Report Number: 1038671-2024-00791
• Device Sequence Number: 20740344
• Product Code: JWH
• UDI-Device Identifier: 10885862001900
• UDI-Public: 10885862001900
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2024

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 Catalogue Number: 02-012-35-4013
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 09/06/2024; Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 09/06/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.
• Patient Age: 58 YR
• Patient Sex: Unknown