MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 15MM; SEE H10

Model Number 204-23-15

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 8850323 208-01-03 - cc femoral sz 3.Pending investigation.

Event Description

It was reported from the legal department that on (b)(6) 2018, a patient underwent a second revision of the left exactech knee device secondary to polyethylene liner wear, approximately 6 years 4 months after the first revision.It is stated that despite undergoing the revision surgeries, 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.

• Brand Name: PS TIBIAL INSERTS SZ 3, 15MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16640217
• MDR Text Key: 312283244
• Report Number: 1038671-2023-00544
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862048332
• UDI-Public: 10885862048332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933610
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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: 204-23-15
• Device Catalogue Number: 204-23-15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2023
• Date Device Manufactured: 11/08/2010
• 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 Sex: Female