MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-03-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 93 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain and discomfort, swelling, mobility impairments, bone deterioration, cysts; ongoing medical care.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 2257190 02-012-49-3509 - logic cr tib insert slope ++, sz 3.5, 9 mm; 4092993 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t; 3847963 200-02-35 - three peg patella 35mm.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
1038671-2024-03610.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, a failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface and the reported pain, and/or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear and femoral debonding could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as no details regarding cementing technique or environmental conditions were provided, and the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC CR FEMORAL CEM, RIGHT, SZ 3.5
• 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: 20516627
• Report Number: 1038671-2024-04095
• Device Sequence Number: 18318299
• Product Code: JWH
• UDI-Device Identifier: 10885862158123
• UDI-Public: 10885862158123
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• 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): 10/31/2024

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: 06/06/2024
• Device Catalogue Number: 02-010-03-0335
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female