MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-23-18
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 60 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, discomfort, and difficulty walking.Plaintiff has suffered, and may continue to suffer, severe and permanent personal injuries, including polyethylene wear and device failure, painful knee revision surgery to remove or revise the defective device, continued rehabilitation, medical care, and possible additional surgeries.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices: 4855763, 02-012-60-1880 - tru stem ext 18mm x 80mm.4872092, 02-012-60-2080 - tru stem ext 20mm x 80mm.4883663, 200-02-38 - three peg patella 38mm.4938129, 208-01-03 - cc femoral sz 3.4939371, 204-04-33 - trapezoid tibial tray sz 3f/3t.5023100, 208-09-05 - cc stem ext adaptor 5 degree.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 the cause or contributor to the reported event.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.

• Brand Name: CC TIBIAL INSERT SZ 3, 18MM
• 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 ; 3523771140
• MDR Report Key: 19466379
• Report Number: 1038671-2024-01740
• Device Sequence Number: 7498562
• Product Code: JWH
• UDI-Device Identifier: 10885862054289
• UDI-Public: 10885862054289
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: 10/08/2018
• Device Catalogue Number: 208-23-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 06/05/2024
• Date Device Manufactured: 10/12/2013
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown