MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 18MM; SEE H10

Model Number 204-23-18

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 9000350 208-01-03 - cc femoral sz 3; 1228459 204-34-04 - fluted stem extension 40l x 14 mm; 1323832 208-05-03 - cc distal fem augment sz 3, 5mm; 1352399 208-05-03 - cc distal fem augment sz 3, 5mm; 2142929 208-09-05 - cc stem ext adaptor 5 degree.Pending investigation.

Event Description

It was reported via legal documents that on (b)(6) 2019, the female patient underwent a second revision of the right exactech knee device secondary to polyethylene liner wear, approximately 6 years 2 months after the first revision procedure.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, 18MM
• 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: 16639996
• MDR Text Key: 312283158
• Report Number: 1038671-2023-00543
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862048349
• UDI-Public: 10885862048349
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2018
• Device Model Number: 204-23-18
• Device Catalogue Number: 204-23-18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/29/2023
• Date Device Manufactured: 01/07/2010
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Female