MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal department, approximately 2.5 months post op the initial left tka, this 69 female patient's was revised due to polyethylene failure.Surgeon was able to remove the polyethylene without incident.It had significant wear, mostly on the medial aspect of the polyethylene.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 200-02-29, 4995177 - three peg patella 29mm; 02-012-45-1515, 5395047 - lgc tibial fit tray cem sz 1.5f / 1.5t; 02-010-03-0215, 5461982 - logic cr femoral cem, left sz 1.5; 02-022-47-1509, 5373513 - truliant tib imp cr ins std sz 1.5, 9 mm.
Additional Manufacturer Narrative
Section h10: (h3) event has been determined to be a duplicate of case-2022-00005290/1038671-2022-00507.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM
• 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: 14944450
• Report Number: 1038671-2022-00766
• Device Sequence Number: 4534896
• Product Code: JWH
• UDI-Device Identifier: 10885862144331
• UDI-Public: 10885862144331
• Combination Product (Y/N): N
• Initial Reporter State: LA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 06/01/2019
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-47-1509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female