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	Pain (1994); Joint Laxity (4526)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G3/4: corrected the following: pma/510(k)number.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 tibial 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.
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case - (b)(6).It was reported that a 65 yo patient, initial left knee implanted on (b)(6) 2014, underwent a revision procedure on (b)(6) 2022, approximately 8 years post the initial procedure.The patient had been seen by the surgeon in an outpatient clinic.The patient had constant pain and instability that failed conservative treatment.The pre-procedure diagnosis indicated aseptic loosening of components, arthroplasty wear of the polyethylene liner.The polyethylene was removed with an osteotome without difficulty.The femoral component was noted to be grossly loose and was dis-impacted without difficulty.The tibial component was noted to be grossly loose and was dis-impacted off the tibial plateau without difficulty and there was minimal bone loss.The tibial stem and bone cement were removed.Competitor¿s devices were re-implanted.The patient was transferred to the post anesthesia care unit in stable condition with stable vital signs having tolerated the procedure well without apparent complications.Revised to stryker.Serial #: (b)(6), category #: 208-25-13 - cc tibial insert sz 5, 13mm, 510k: k954208 jwh z-0019-2022 concomitants: serial #: (b)(6), category #: 204-04-55 - trapezoid tibial tray sz 5f/5t, serial #: (b)(6), category #: 200-02-35 - three peg patella 35mm, serial #: (b)(6), category #: 204-34-08 - fluted stem extension 80l x 14 mm, serial #: (b)(6), category #: 204-38-12 - stem extension w/slot 120l x18 mm, serial #: (b)(6), category #: 208-09-05 - cc stem ext adaptor 5 degree, serial #: (b)(6), category #: 208-01-05 - cc femoral sz 5, serial #: (b)(6), category #: 1510-s - cemex system fast 70 gm.

• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20532451
• Report Number: 1038671-2024-04119
• Device Sequence Number: 8218757
• 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: 2014
• 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
• Report Date (Section B): 11/12/2024

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: 04/09/2016
• Device Catalogue Number: 208-01-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2011
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male