MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CC TIB INSERT SIZE 3, 13MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 5.5 years post initial right tka, surgeon preformed a poly swap to the (b)(6) female patient due to instability.There was no breakage of device or surgical delay/prolongation.Sales rep was unable to obtain photos/x-rays.The product is not available for return.
Additional Manufacturer Narrative
(h3) it was reported from the us that a 64 yo female, weight 103 lbs, experienced a surgical revision.Approximately 5.5 years post right tka, surgeon preformed a poly swap due to instability.There was no breakage of device or surgical delay/prolongation.Sales rep was unable to obtain photos/x-rays.The product is not available for return.Patient has had two revision surgeries prior to this one.The first was on (b)(6) 2016 and the second revision was on (b)(6) 2016.Patient was last known to be in stable condition following the event.Unable to obtain photos/x-rays.Product is not available for return.No additional information is available.Upon review of all available information, there is no evidence to suggest that a design issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.These devices are used for treatment not diagnosis.

• Brand Name: LOGIC CC TIB INSERT SIZE 3, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14622959
• Report Number: 1038671-2022-00636
• Device Sequence Number: 14737662
• Product Code: JWH
• UDI-Device Identifier: 10885862266002
• UDI-Public: 10885862266002
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 10/15/2023
• Device Model Number: LOGIC CC TIB INSERT SIZE 3, 13MM
• Device Catalogue Number: 02-012-65-3013
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 47 KG