MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 2, 18MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 204-38-12 - stem extension w/slot 120l x18 mm sn: (b)(4), 208-01-02 - cc femoral sz 2 sn: (b)(4), 208-06-02 - cc distal fem augment sz 2, 10mm sn: (b)(4), 208-07-02 - cc posterior fem augment sz 2, 5mm sn: (b)(4), 208-07-02 - cc posterior fem augment sz 2, 5mm sn:(b)(4), 208-09-05 - cc stem ext adaptor 5 degree sn: (b)(4).
Event or Problem Description
As reported by legal, that this patient's right knee was revised 09/01/2015.Second revision date: (b)(6) 2021; reason for the revision was not reported.No additional information provided.First revision reported under report # 1038671-2022-00990.
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.H7: z-0019-2022.
Additional Manufacturer Narrative
H6: corrected medical device problem code, component code, type of investigation, and investigation findings.Manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and/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, radiographs, and relevant clinical information were not provided.

• Brand Name: CC TIBIAL INSERT SZ 2, 18MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15334372
• Report Number: 1038671-2022-00991
• Device Sequence Number: 6927657
• Product Code: JWH
• UDI-Device Identifier: 10885862054203
• UDI-Public: 10885862054203
• 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: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: CC TIBIAL INSERT SZ 2, 18MM
• Device Catalogue Number: 208-22-18
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 09/08/2022; 10/15/2024
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/28/2022; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female