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); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.D 10: concomitants: (b)(6), 620-00-02 - platelet rich plasma kit with spray tips; (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6), 200-02-35 - three peg patella 35mm; (b)(6), 620-12-02 - accelerate prp 60 ml & acd-a.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2014, and then experienced revision surgical procedure on (b)(6) 2022 approximately 8 years and 2 months after initial implant due to extensive osteolysis and large cyst formation of the medial femoral condyle and ploy wear.No images were provided.There is no other information available.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.Operative report from revision surgery attached.No further information.Serial number, item number and full description: (b)(6), 02-012-44-4011 - logic tibia implant psc insert, sz 4, 11mm; serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510(k): k110547.Concomitants: (b)(6), 620-00-02 - platelet rich plasma kit with spray tips; (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), 200-02-35 - three peg patella 35mm; (b)(6), 620-12-02 - accelerate prp 60 ml & acd-a.As directed by qa management: this legal complaint case is from the united states.The event did not occur in, nor is it reportable for brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2014, and then experienced revision surgical procedure on (b)(6) 2022 approximately 8 years and 2 months after initial implant due to extensive osteolysis and large cyst formation of the medial femoral condyle and ploy wear.No images were provided.There is no other information available.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record and smartsolve searched for sn/patient name with no results.Operative report from revision surgery attached.No further information.As directed by qa management: this legal complaint case is from the united states.(b)(4).Therefore, only the us reportability determination will be assessed.
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 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 and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2014, and then experienced revision surgical procedure on (b)(6) 2022 approximately 8 years and 2 months after initial implant due to extensive osteolysis and large cyst formation of the medial femoral condyle and poly wear.No images were provided.There is no other information available.

• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20734582
• Report Number: 1038671-2024-04442
• Device Sequence Number: 15684105
• 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: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2025

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: 05/06/2019
• Device Catalogue Number: 02-010-01-0340
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 11/20/2024; 03/18/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 11/20/2024; 03/18/2025
• Date Device Manufactured: 05/08/2014
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male