MAUDE Adverse Event Report: EXACTECH, INC. CC FEMORAL SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-01-02
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6) 02-012-45-2020 - bandeja tibial logic fit 2f/2t.(b)(6) 204-34-08 - vastago ext.14x80mm.(b)(6) 204-36-08 - vastago ext.16x80mm.(b)(6) 208-01-02 - femur cc nº2.(b)(6) 208-09-07 - adaptador femoral vastago cc 7 grados.H3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the patient was indicated with pain and mechanical failure, swollen knee and early signs of osteolysis observed in (b)(6) of 2021.Subsequently, in (b)(6) 2022 the patient was indicated with massive osteolysis in both tibia and femur.In (b)(6) 2023 the patient underwent left knee revision surgery.It was noted osteolysis was confirmed, femoral component found to be loose (aori type 3).Tibial bone loss classified as aori type 2a in the medial compartment.It was noted that the surgeon attempted implantation of johnson & johnson sleeves, but fixation was not achieved.Ultimately, a link hinge prosthesis with metaphyseal cones was implanted.Patient was revised to a competitor's construct.It was reported the event was not related to the breakage of a device.No medical or surgical interventions were reported.No patient impact or outcome was reported.A photo of the explanted insert was provided.No x-rays were obtained.No additional information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: type of investigation, investigation findings, investigation conclusions.The revision reported was likely caused by osteolysis, prosthesis wear, or the reported femoral loosening.Possible causes for polyethylene wear include the alleged femoral loosening, rotation or malalignment of the femoral component such that the femoral condyle or cam radius contacts the tibial spine, inclusion of the polyethylene in the packaging recall or any combination of these possibilities.Failure of the cement used to secure the femoral component to the femoral bone, may have led to loosening at the cement-implant and/or cement-bone interface, however, this cannot be confirmed as images of the explanted device and pre-revision radiographs were not provided.

• Brand Name: CC FEMORAL SZ 2
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22054853
• Report Number: 1038671-2025-02101
• Device Sequence Number: 14495986
• Product Code: JWH
• UDI-Device Identifier: 10885862053213
• UDI-Public: 10885862053213
• 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: 2016
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 08/19/2025

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: 02/17/2020
• Device Catalogue Number: 208-01-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 83 KG