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 Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, the 56-year-old male had a left tka on (b)(6) 2013.The patient presented with inflammation / polyethylene wear without evidence of osteolysis on (b)(6) 2021 the action taken is other - arthroscopic synovial biopsy of right knee.This was a day case procedure, and upon review, was found to have been recorded as inpatient hospitalization.This is now considered an ae, not and sae and the outcome of this event is considered resolved on (b)(6) 2021.The case report form indicates that this event is possibly related to the device and definitely related to the procedure.This event is related to (b)(4) and was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
Concomitant device(s): 02-010-01-0340 - logic femoral ps cem right sz 4 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t 200-02-38 - three peg patella 38mm pending evaluation.
Additional Manufacturer Narrative
This case was found to be a duplicate of (b)(4) and all information was reported via 1038671-2023-00563.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The arthroscopic synovial biopsy and debridement reported may have been due to prosthesis wear of the tibial insert and inflammation.However, the reported event cannot be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be fully assessed as the devices were not available for evaluation and no images, radiographs, manufacturing lot information, or detailed clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19317015
• Report Number: 1038671-2024-01252
• Device Sequence Number: 18057249
• 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: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/15/2025

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?: 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: 04/25/2024
• Supplement Date Received by Manufacturer: Not provided; 09/06/2024; 11/14/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/29/2024; 09/06/2024; 01/15/2025
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG