MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 3962002 02-012-44-5009 - logic tibia implant psc insert, sz 5, 9mm 4047566 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t 4187043 200-02-35 - three peg patella 35mm multiple mdr reports were filed for this event, please see associated reports: (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported via legal documentation that approximately 90 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain and discomfort in the knee with swelling.Preoperative and postoperative diagnosis: failed total knee arthroplasty, right.Findings: there was significant fluid and synovitis throughout the joint.There was some questionable loosening from the superior flange.It was easily debonding the femoral component from the cement was easily done.Behind this, there was a significant cyst in the lateral femoral condyle.Description of procedure: fluid was expressed.After removing all the fluid, there was significant synovitis, and extensive debridement was performed externally and internally.The tibia was removed.There was significant posterior wear of the poly with some delamination at the very posterior corner, especially laterally.We then began evaluating the femoral component.We were concerned there was some loosening and indeed it was easily able to be removed with osteotomes debonding from the cement.We also noted there was a large cyst, marble size of the lateral femoral condyle.The patient was revised to exactech devices.No other issues or complications were reported.The patient was awakened and taken to recovery room in good condition.No additional information is available.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 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
• MDR Report Key: 20738572
• Report Number: 1038671-2024-04456
• Device Sequence Number: 8649563
• Product Code: JWH
• UDI-Device Identifier: 10885862001269
• UDI-Public: 10885862001269
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: 08/16/2020
• Device Catalogue Number: 02-010-01-0350
• 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: 11/13/2024
• Initial Report FDA Received Date: 11/20/2024
• Date Device Manufactured: 08/19/2015
• 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: 59 YR
• Patient Sex: Male