MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 2, 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	01/01/2023
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 four years post initial left tka, the 68 y/o female patient had a poly swap for an unknown reason.Patient was revised to exactech device.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The device is not available for evaluation as the device was kept by the hospital.
Additional Manufacturer Narrative
H11.Correction- upon investigation this has been identified as a duplicate case- all information will be captured, processed, and reported under mfr# 1038671-2023-02181.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM
• 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: geoff gannon ; 3523771140
• MDR Report Key: 17588050
• Report Number: 1038671-2023-02002
• Device Sequence Number: 14060841
• Product Code: JWH
• UDI-Device Identifier: 10885862174284
• UDI-Public: 10885862174284
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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 Expiration Date: 08/01/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM
• Device Catalogue Number: 02-012-48-2009
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; LOGIC CR FEMORAL CEM, LEFT SZ 2; THREE PEG PATELLA 29MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female