MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0340
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint effusion (4849)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0340 - logic femoral ps cem right sz 4; (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6), 200-02-38 - three peg patella 38mm.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.
Event or Problem Description
Legal case ¿ usa (master case no.(b)(4)).Patient id: (b)(6).10/11/2024: additional information received in inbox on 10/11/2024.Attached email and revision op report.Revision surgery operative noted were provided.Preoperative diagnosis: right failed painful total knee replacement.Postoperative diagnosis: right failed painful total knee replacement plus femoral osteolysis of the medial posterior and lateral condyle, grossly loose femoral component, advanced wear of the patella, polyethylene on the tibial insert with delamination.Indication: the patient is a 59-year-old male who has been suffering with recurrent effusions, pain and stiffness.The previous x-rays and mri demonstrated osteolysis with loosening of the femoral component.Description of the procedure: there was lateral wear of the patella button.The patellar button was well fixed.Electrocautery was used to clean the fibrosis from the margin of the femoral component.The femoral component appeared to be grossly loose.A reciprocating saw was used to break the interface between the implant and the cement.At this point, the femoral implant was tapped out with complete debonding of the cement and the implant.There was significant osteolysis of the posterior medial and posterior lateral and distal femoral condyles.Electrocautery was used to remove the fibrosis covering the osteolysis.The tibial baseplate was well fixed.A combination of reciprocating saw, microsaw, and osteotomes were used to remove the tibial component.The tibial component was carefully removed with minimal bone loss.The oscillating saw was used to remove the patella which appeared to be well fixed with moderate lateral osteolysis.The patient was revised to a competitor¿s devices.The patient was extubated and transferred to pacu.There were no complications noted.No additional information is available.It was reported that approximately 123 months after a right knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.No further issues or complications were reported.No additional information is available.Product: 2252298, 02-012-35-4011 - logic tibia ps mod insrt sz 4 11mm; 510k: k033883; udi: (b)(4); product code: jwh; x-ray: no; operative notes: no.Concomitants: (b)(6), 02-010-01-0340 - logic femoral ps cem right sz 4; (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6), 200-02-38 - three peg patella 38mm.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 4
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20514103
• Report Number: 1038671-2024-04090
• Device Sequence Number: 12533245
• Product Code: JWH
• UDI-Device Identifier: 10885862001252
• UDI-Public: 10885862001252
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 02/13/2017
• Device Catalogue Number: 02-010-01-0340
• 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: 10/11/2024
• Initial Report FDA Received Date: 10/23/2024
• Date Device Manufactured: 02/15/2012
• 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 Sex: Unknown