MAUDE Adverse Event Report: BIOMET MICROFIXATION TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; TMJ FOSSA

Model Number N/A

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

It is reported a stock tmj was implanted nine (9) years ago.A revision surgery was being performed because the surgeon thought the patient had an infection in her joint.During the surgery they identified the condyle head was broken, which was causing discomfort and pain.The surgeon indicated that he believes the fracture of the implant may have occurred due to an impact on the surgical site itself.

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.The part and lot numbers are unknown; therefore the device history records are unable to be reviewed.The user facility is foreign; therefore a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.File one of four for the same event, see also 1032347-2015-00277, 1032347-2015-00278 and 1032347-2015-00279.

• Brand Name: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: TMJ FOSSA
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4888738
• MDR Text Key: 6264278
• Report Number: 0001032347-2015-00276
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN FOSSA
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention