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

Catalog Number	208-01-05
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00689, 1038671-2025-00125.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and fracture 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.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
As reported by legal documentation, that approximately 9 years and 4 months after a right total knee replacement procedure, the patient experienced prosthesis wear, instability, femoral loosening, cyst(s), joint effusion, osteolysis, swelling/ edema, joint laxity and implant pain.Revision operative report- the patient presented with a painful constrained right knee replacement.The patient was noted to have marked wear of the polyethylene on x-ray, but not gross evidence of loosening.He had a large effusion and popliteal cyst that was painful.The patient has failed conservative management including activity modification and anti-inflammatory medications.There was very extensive synovitis and a very thorough synovectomy of the joint was performed.The polyethylene liner was removed.There was noted to be severe wear of the liner with delamination.Next the femoral component was noted to be loose and there was a fracture of the stem at the femoral component junction.The femoral component and stem were removed.There was significant fibrous tissue beneath it with marked osteolysis.There was no evidence of infection grossly although multiple specimens were sent to pathology.Attention was then turned to the tibia.There was some peripheral osteolysis.The patella was noted to be well fixed, but there was some wear on the patella.The patient was transferred to the recovery room in stable condition.No additional information is available.

• Brand Name: CC FEMORAL 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21095535
• Report Number: 1038671-2025-00127
• Device Sequence Number: 15743562
• Product Code: JWH
• UDI-Device Identifier: 10885862053244
• UDI-Public: 10885862053244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 04/06/2015
• Device Catalogue Number: 208-01-05
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2010
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male