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

Catalog Number	02-012-48-2009
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Anxiety (2328)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2016 and then experienced a revision surgical procedure on (b)(6) 2023 approximately 6 years and 7 months after initial implant.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants; 4041259 521-78-31 - threaded pin size 2.6 collarless 2pk, 4144517 521-78-31 - threaded pin size 2.6 collarless 2pk, 4560588 02-010-03-0220 - logic cr femoral cem, left sz 2, 4564771 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t, 4598585 200-02-32 - three peg patella 32mm.
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 loss of range of motion and/or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear and loss range of motion could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 2, 9MM
• 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: matt collins
• MDR Report Key: 19122653
• Report Number: 1038671-2024-00884
• Device Sequence Number: 8359316
• Product Code: JWH
• UDI-Device Identifier: 10885862174284
• UDI-Public: 10885862174284
• 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: 2016
• 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): 10/09/2024

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: 07/29/2019
• Device Catalogue Number: 02-012-48-2009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 10/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown