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	Osteolysis (2377)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, the 72-year-old patient had a left tka on (b)(6) 2016.The patient presented with polyethylene wear w/evidence of osteolysis on (b)(6) 2021.The patient experienced swelling in left knee, surgeon reports this is due to the polyethylene wear which is visible on the x-ray with evidence of osteolysis.No action was taken and the outcome of this event is considered continuing.The case report form indicates that this event is possibly related to the device and definitely not related to the procedure.This event report is related to (b)(6) and was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
It was discovered that this case is a duplicate of (b)(4) and was created in error.Report 1038671-2021-00691 was submitted for this event.

• 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: 19316276
• Report Number: 1038671-2024-01250
• Device Sequence Number: 20422682
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 04/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/09/2024
• 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: 77 YR
• Patient Sex: Unknown
• Patient Weight: 86 KG