MAUDE Adverse Event Report: BIOMET MICROFIXATION TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; 45MM RIGHT NARROW MANDIBULAR

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 12/28/2015

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.Report two of six for the same event, see also 0001032347-2016-00029, and 00031 through 00034.

Event Description

The surgeon's assistant reported a revision of the right fossa.At the age of (b)(6), the patient received the biomet tmj implant due to functional deformity of the tmj.The patient had a revision surgery on (b)(6) 2015 with the following pre-op diagnoses: goldenhar's syndrome, right tmj fossa defect, mandibular asymmetry, and malposition of tooth #5.During the revision surgery the right fossa was explanted and the reconstruction was done with a custom concept fossa prosthesis.It was verbally reported that "the biomet prosthesis was loose in place.Related to the baseline condition of this patient.Being necessary the reconstruction with a custom device.".

Manufacturer Narrative

All parts reported for this event were returned for the complaint of a revision as a result of a functional deformity.A visual inspection of the implant and the patient¿s scans confirms the complaint.The most likely underlying cause of the complaint is patient¿s condition.There are no indications of a manufacturing defect.Under warnings in the ifu (instructions for use), it is stated, ¿do not use in children.The total tmj replacement was designed for skeletally mature patients." this statement forewarns about using this implant on patients that are still in the process of growing.The patient was approximately (b)(6) at the time of implantation.This is report 2 of 6 for the same event.Reports 1, and 3 through 6 are reported on mfr #0001032347-2016-00029-1 and 0001032347-2016-00032-1 through 0001032347-2016-00034-1.

• Brand Name: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: 45MM RIGHT NARROW MANDIBULAR
• 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: 5411969
• MDR Text Key: 37524720
• Report Number: 0001032347-2016-00030
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: N/A
• Device Catalogue Number: 01-6545
• Device Lot Number: 328500A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 02/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 17 YR