MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	200-21-09
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Implant Pain (4561); Insufficient Information (4580)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient underwent testing and received a right knee replacement in 2011 and 2012.Early on, the patient experienced initial and continuing pain and problems with her right knee after the surgery, requiring repeated procedures to drain fluid from her right knee, with biopsies of the fluid, x¿rays, and ct scans to try to determine the source of the problems that she was experiencing.In 2013 to 2014, with the original treating physician now retired, the patient was referred to another surgeon.The surgeon continued to investigate and treat the problems with the patient¿s knee, resulting in a surgical revision to the original knee replacement, which required replacing the original device with an exactech knee replacement device.Explanation date/occurrence date of the first revision surgery is currently unknown.
Additional Manufacturer Narrative
D10: concomitants: (b)(4) 232-03-01 - optetrak asy, cr porous femoral, sz 1, right, (b)(4) 204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t, (b)(4) 650-00-05 - optecure 5cc rt, (b)(4) 200-02-29 - three peg patella 29mm.Pending investigation.
Additional Manufacturer Narrative
H10.Additional information- d6b revision date not provided, g2, h8.H3.Investigation results-the cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Pain is a known event with joint replacement procedures.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: CR TIBIAL INSERT SZ 1, 9MM
• 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: 17859707
• Report Number: 1038671-2023-02438
• Device Sequence Number: 5729902
• Product Code: JWH
• UDI-Device Identifier: 10885862040145
• UDI-Public: 10885862040145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 04/09/2018
• Device Catalogue Number: 200-21-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2010
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown