MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Synovitis (2094); Insufficient Information (4580)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee revision of (b)(6) 2016.Approximately 6 years and 9 months after the first revision the patient had a second right knee revision on (b)(6) 2023.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.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.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.
Additional Manufacturer Narrative
Recall number: z-0019-2022.1038671-2024-05060, 1038671-2024-05059 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-05060, 1038671-2024-05059 the following sections were updated: d4, g1, g3/g4, h4, h6 the following sections were corrected: a2, a3, b1, b2, d1, d4, g1, h6 d10: concomitants: 4179215 204-32-12 - stem extension 120l x12 mm 4200005 204-38-12 - stem extension w/slot 120l x18 mm 4062161 208-01-04 - cc femoral sz 4 2351646 208-04-44 - trap tray, offset beta cem., sz 4f/4t 2503813 208-04-74 - screw, offset, sz ff 4177904 208-05-04 - cc distal fem augment sz 4, 5mm 4141391 208-09-05 - cc stem ext adaptor 5 degree the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, femoral bone fracture, 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CC TIBIAL INSERT SZ 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 17815843
• Report Number: 1038671-2023-02369
• Device Sequence Number: 16754075
• Product Code: JWH
• UDI-Device Identifier: 10885862054340
• UDI-Public: 10885862054340
• 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: 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): 12/30/2024

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: 01/01/2018
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 208-24-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2013
• 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.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female