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

Model Number 200-22-09

Device Problem Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 09/18/2018

Event Type  Injury  

Event Description

It was reported from the legal department that on (b)(6) 2018, the patient underwent revision of the left knee device secondary to ongoing osteolysis due to polyethylene liner wear resulting in aseptic loosening of the femoral and tibial components and bone grafting of the femur.It is also stated that despite undergoing the revision surgery, the patient experiences daily knee pain and discomfort which limit activities of daily living and recreation and impacts quality of life.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

D2b, knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.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.

• Brand Name: CR TIBIAL INSERT SZ 2, 9MM
• 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: 16606643
• MDR Text Key: 311924146
• Report Number: 1038671-2023-00501
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862040190
• UDI-Public: 10885862040190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932776
• 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: 03/23/2023

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: 05/05/2018
• Device Model Number: 200-22-09
• Device Catalogue Number: 200-22-09
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/23/2023
• Date Device Manufactured: 05/06/2010
• 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-0019-20221
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male