MAUDE Adverse Event Report: EXACTECH, INC. CC FEMORAL SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Insufficient Information (4580)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee revision on (b)(6) 2015.Approximately 6 years and 11 months after the first revision the patient had a second right knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of (b)(6).Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.
Additional Manufacturer Narrative
H10.Additional/updated information- a2, a3, b5, d1, d4 all, d10, g4 510k, h4, h6 health effect - clinical code & medical device problem code.Investigation pending.H11.Correction- f6, f9, f10 should be blank.
Event or Problem Description
Additional information received from legal on (b)(6) 2023* revision op report and device information.This information does not affect the reportability assessments/severity.Revision operative report of (b)(6) 2022-the patient was revised to competitor¿s devices.Procedure: revision right total knee arthroplasty.Intraoperative findings: loose femoral implants - removed easily with severe bone loss.Very extensive bone loss on the distal femur because of osteolysis.Soft tissue sent to pathology.During the extraction of the femoral implant the lateral condyle fracture 100% - this was reduced and fixed with screws x 2, and a distal femoral cone to anchor the lateral condyle as well-packed with bone graft mixed autograft and allograft.The patella was exposed, and the patellar button was well fixed and stable, it was retained.Sterile dressing applied.Patient reversed from anesthesia and sent to pacu in stable condition.No additional information available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, 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.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: CC FEMORAL SZ 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; gainesville 32653 ; 3523771140
• MDR Report Key: 17772195
• Report Number: 1038671-2023-02304
• Device Sequence Number: 7163079
• Product Code: JWH
• UDI-Device Identifier: 10885862053244
• UDI-Public: 10885862053244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 208-01-05
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 01/28/2025
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/02/2023; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2015
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male