MAUDE Adverse Event Report: EXACTECH, INC. CC FEMORAL SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-01-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.It was reported a patient underwent a left total knee revision procedure approximately three (3) years later, the patient was diagnosed with aseptic loosening of the femoral component.It was reported the reason for the loosening was unclear.As a result, a year later, the patient underwent a second (2nd) revision procedure.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
D10: 02-11 232-02-03 - porous asymmetric femoral comp.Cr nº3 izq 274452; 02-012-45-3040 - logic fit 3f/4t tibial tray 274452; 200-02-32 - three-lug ball joint 32 mm 274452; 204-34-04 - ext.14 x 40 mm stem 274452; 204-34-08 - ext.Stem 14 x 80 mm 274452; 208-01-03 - femur cc nº3 274452; 208-09-05 - 5 degree dc rod femoral adapter 274452; 208-23-13 - tibial insert cc 3.13 mm 274452.G2 (spain).H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01070.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing data was performed and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.The revision may have been the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.However, this cannot be confirmed because the component was not returned for evaluation and images were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CC FEMORAL SZ 3
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24905356
• Report Number: 1038671-2026-00442
• Device Sequence Number: 9799826
• Product Code: JWH
• UDI-Device Identifier: 10885862053220
• UDI-Public: 10885862053220
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 03/22/2023
• Device Catalogue Number: 208-01-03
• 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: 10/10/2023
• Initial Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 03/26/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 75 KG