MAUDE Adverse Event Report: BIOMET MICROFIXATION TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; 55MM RIGHT STANDARD MANDIBLE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abscess (1690); Fistula (1862)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

Based on the information available at this time the most likely root cause of the event is the patient's condition.A follow up report will be sent upon completion of the device evaluation.Report one of four for the same event, reference 1032347-2016-00373 through 1032347-2016-003735.

Event Description

The sales associate reported the joint was implanted (b)(6) 2014 and a revision due to infection was performed on (b)(6) 2016.It was reported the joint remained implanted with no issues, then at some point in the past couple of months an abscessed fistula developed on the patients right jaw.The surgeon found the abscess created a loosening of the implants.

Manufacturer Narrative

The products were returned for evaluation.The product identities were confirmed in the evaluation.A visual inspection revealed a bony ingrowth on the mandible implant, minor scratches on the surface of the implant where the screws were inserted, and minor wear on the anodize coating around the head of the screws.Because the implants were revised due to the abscessed fistula, the complaint is confirmed.The most-likely cause was determined to be patient's condition.The non-conformance database was reviewed in the evaluation for the mandible implant and no non-conformances were found.The lot numbers for the screws are still unknown, therefore, the device history records could not be reviewed in the evaluation.According to the evaluation, there are no indications of manufacturing defects.Based on the product evaluation, the following were updated: date received by mfr, if follow-up, what type?, device evaluated by mfr?, evaluation codes, and additional mfr narrative.This is report one of four for the same event.Reports two through four are reported on mfr #0001032347-2016-00373-1 through 0001032347-2016-00375-1.

• Brand Name: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: 55MM RIGHT STANDARD MANDIBLE
• 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: 5846802
• MDR Text Key: 51157223
• Report Number: 0001032347-2016-00372
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

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: 09/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6555
• Device Lot Number: 557410A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR