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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The lot number is 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.Report ten of eleven for the same event, reference 1032347-2015-00460 through -00470.

Event Description

The distributor reported a revision is planned for (b)(6) 2015 due to the prosthesis shifting to the right.She reported in (b)(6) 2008 the right prosthesis was placed , and in (b)(6) 2010 the left prosthesis was placed.The surgeon was inquiring on the possibilities of relocating the same prosthesis during the revision surgery, however we advised these implants are single use.

Manufacturer Narrative

Additional information was received from the sales associate, she stated the revision surgery was performed (b)(6) 2015.She stated the implants were removed and replaced with new implants.It is reported the explanted devices were discarded.In addition, she reported the revision surgery was perfect and the patient is doing perfectly now.Supplemental report ten of eleven for the same event, reference 1032347-2015-00460-1 through -00470-1.

• Brand Name: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: TMJ SM LFT FOSSA COMPONENT
• 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: 5225786
• MDR Text Key: 31313613
• Report Number: 0001032347-2015-00469
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

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 Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• 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
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention