MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Implant Pain (4561)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 4539517 02-010-03-0250 - logic cr femoral cem, left, sz 5 5475591 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t 5623493 200-02-35 - three peg patella 35mm the device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 54 months after a left total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, pain, suffering, physical injury and bodily impairment, harm, mental and emotional distress.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report 1038671-2023-01813.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 5, 11MM
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19306133
• Report Number: 1038671-2024-01221
• Device Sequence Number: 15062441
• Product Code: JWH
• UDI-Device Identifier: 10885862174628
• UDI-Public: 10885862174628
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: 12/07/2020
• Device Catalogue Number: 02-012-49-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown