MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT STD, SZ 3, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526); Joint effusion (4849)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2013.Approximately 9 years and 6 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023: diagnosis: failed right patella implant and polyethylene insert polyethylene insert was removed which showed excessive wear.The patella everted, showed extensive wear.The patient was brought to recovery room in stable condition.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 200-03-32 - one peg patella 32mm, (b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, (b)(6) 02-010-03-0330 - logic cr femoral cem, right, sz 3, (b)(6) 201-78-25 - small headed sharp pin, 1 1/8" 4 pack.Pending investigation.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 17823824
• Report Number: 1038671-2023-02382
• Device Sequence Number: 12302385
• Product Code: JWH
• UDI-Device Identifier: 10885862174352
• UDI-Public: 10885862174352
• 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: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 03/05/2021
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3, 11MM
• Device Catalogue Number: 02-012-47-3011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 12/09/2024
• Date Device Manufactured: 03/13/2013
• 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: A
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male