MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 6, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CR TIB INSERT STD, SZ 6, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of increased soft-tissue laxity.However, the contributions of patient-related conditions, implant alignment, and/or wear to the reported revision cannot be determined from the information provided and the devices not being available for evaluation.The most probable root cause associated with undesirable stability of the joint or implant construct.
Event or Problem Description
As reported, approximately 1.5 years postop the initial implant, this (b)(6) y/o male patient's right patella facetectomy was completed.A revision for liner exchange performed due to knee being in slight valgus still to relieve ap instability.Patient was last known to be in stable condition following the event.The original liner was disposed of at hospital.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 6, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11315150
• Report Number: 1038671-2021-00033
• Device Sequence Number: 11395404
• Product Code: JWH
• UDI-Device Identifier: 10885862174642
• UDI-Public: 10885862174642
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 6, 9MM
• Device Catalogue Number: 02-012-47-6009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 80 YR