MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3509
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Balance Problems (4401); Joint Laxity (4526)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 109 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, osteolysis, and aseptic loosening of the femoral component.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitant devices (b)(6) 02-010-03-0335 - logic cr femoral cem, right, sz 3.5 (b)(6) 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t (b)(6) 200-02-35 - three peg patella 35mm (b)(6) 201-78-89 - 3" drill bit, mod.Hex 2 pack (b)(6) 201-78-97 - 2 pk, schanz pin, 3mm x 145mm (b)(6) 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
H6: corrected the following: health effect clinical code, medical device problem code, type of investigation manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability and femoral loosening 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, radiographs, and relevant clinical information were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 9 MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19515357
• Report Number: 1038671-2024-01904
• Device Sequence Number: 3328136
• Product Code: JWH
• UDI-Device Identifier: 10885862159311
• UDI-Public: 10885862159311
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2020
• Device Catalogue Number: 02-012-49-3509
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown