MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 2, LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CC FEMORAL SIZE 2, LEFT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: stem (cat# 02-012-69-1412 / serial# (b)(4).Logic offset stem ext coupler 2mm (cat# 02-012-61-2000 / serial# (b)(4).Logic cc tib insert size 2, 17mm (cat# 02-012-65-2017 / serial# (b)(4).Cc distal fem augment sz 2, 5mm (cat# 208-05-02 / serial# (b)(4).Cc distal fem augment sz 2, 5mm (cat# 208-05-02 / serial# (b)(4).As reported, approximately 3 years postop the initial l tka, this (b)(6) y/o female patient was unhappy with her left knee, so a revision was done with some change in rotation.Revision exactech cc knee to a revision exactech cc knee.Patient was last known to be in stable condition following the event.The device will be returned for evaluation.Upon review, there is no allegation against the device as the reason for revision was not reported other than patient was "unhappy" with no specifics reported.The most likely cause of the reported event is patient conditions.
Event or Problem Description
As reported, approximately 3 years postop the initial l tka, this (b)(6) y/o female patient was unhappy with her left knee, so a revision was done with some change in rotation.Revision exactech cc knee to a revision exactech cc knee.Patient was last known to be in stable condition following the event.

• Brand Name: LOGIC CC FEMORAL SIZE 2, LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11586364
• Report Number: 1038671-2021-00136
• Device Sequence Number: 4297515
• Product Code: JWH
• UDI-Device Identifier: 10885862265654
• UDI-Public: 10885862265654
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 02/19/2022
• Device Model Number: LOGIC CC FEMORAL SIZE 2, LEFT
• Device Catalogue Number: 02-010-06-0220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/29/2021
• 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: 58 YR