MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++; SEE H10

Model Number 200-72-09

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 03/30/2017

Event Type  Injury  

Event Description

Additional information received by the legal department on (b)(6) 2023 : on (b)(6) 2023 , the patient underwent a left total knee replacement.On (b)(6) 2017, the patient underwent revision of the exactech knee device secondary to polyethylene liner wear with resulting osteolysis, liner breakage, and aseptic loosening.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.

Manufacturer Narrative

Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 2429019 200-02-32 - three peg patella 32mm; 2559397 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t; 2382142 230-02-02 - optetrak asy,cr cemented femoral, sz 2.Initial mdr and fu1 reported under mfr# 1038671-2017-00216 reported under historical system, prior to electronic complaint handling system.

• Brand Name: CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16617385
• MDR Text Key: 312106923
• Report Number: 1038671-2023-00512
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862041210
• UDI-Public: 10885862041210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2018
• Device Model Number: 200-72-09
• Device Catalogue Number: 200-72-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0019-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male