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

Model Number	CC FEMORAL SZ 5
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2011
Type of Reportable Event	Serious Injury
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
Additional information received from legal on 28-dec-2023.Legal case ¿ usa.Patient id: (b)(6) lk rev 2.Related (b)(4) lk rev 1.Implant date: (b)(6) 2011, dr.(b)(6), explant date: (b)(6) 2017, dr.(b)(6).No device return anticipated due to this being a legal case.Unable to locate surgeon/patient/serial number in ebi.Serial numbers provided.(b)(6), 208-25-22 - insert, tibia constrained condylar.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k954208.Concomitants: optetrak femoral constrained condylar cemented (cat.No.Unknown, sn (b)(6)).Extension, femoral fluted stem with slot (cat.No.Unknown, sn (b)(6)).Augment, femoral posterior (cat.No.Unknown, sn (b)(6)).Augment, femoral distal (cat.No.Unknown, sn (b)(6)).Augment, femoral distal (cat.No.Unknown, sn (b)(6)).Adapter, femoral taper with screw (cat.No.Unknown, sn (b)(6)).Stryker simplex with tobra bone cement.Original description summary: legal case - (b)(6).Patient id: (b)(6) lk rev2.Refer to case- (b)(4) lk rev1.As reported via legal documentation, a patient had their first left knee revision surgery on (b)(6) 2011.They subsequently underwent a second left knee revision on (b)(6) 2017, approximately 5 years 5 months after their preceding revision.The patient claims to have suffered pain since the implanted device and continues to face pain.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.**10 jan 2024, (b)(6), rn-the patient has filed a complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.(b)(4), and pending in the eastern district of (b)(6).Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.Ebi initial surgery search - no results.
Additional Manufacturer Narrative
B4: corrected.
Event or Problem Description
As reported via legal documentation, a patient had their first left knee revision surgery on (b)(6)2011.They subsequently underwent a second left knee revision on (b)(6)2017, approximately 5 years 5 months after their preceding revision.The patient claims to have suffered pain since the implanted device and continues to face pain.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, tibial loosening, and femoral 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.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 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21246512
• Report Number: 1038671-2025-00458
• Device Sequence Number: 8606143
• 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: 2011
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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: 05/31/2015
• Device Model Number: CC FEMORAL SZ 5
• Device Catalogue Number: 208-01-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 02/03/2025; 04/15/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/03/2025; 04/16/2025
• Date Device Manufactured: 06/02/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male