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

Catalog Number	204-01-03
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)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report numbers: 1038671-2024-02432 and 1038671-2024-04482 d10 concomitant devices: (b)(6) 204-04-32 - trapezoid tibial tray sz 3f/2t (b)(6) 204-34-08 - fluted stem extension 80l x 14 mm (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6) 203-90-03 - 11-3978 stablecut gts osc system 6105x19x1.27 (b)(6) 203-96-41 - (11-3974) stryker sys 6 90x13x1.27 (b)(6) 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19 multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-02432 and 1038671-2024-04482 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.The reported femoral debonding may have been the result of failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided.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
It was reported via legal documentation that approximately 117 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening, pain, osteolysis, failure of implant.Revision surgery operative notes were provided.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d4.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.The reported femoral debonding may have been the result of failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided.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.

• Brand Name: PS CEMENTED 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 20765743
• Report Number: 1038671-2024-04483
• Device Sequence Number: 9446607
• Product Code: JWH
• UDI-Device Identifier: 10885862047588
• UDI-Public: 10885862047588
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K933494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 04/24/2012
• Device Catalogue Number: 204-01-03
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2007
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female