• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT 50 MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET MICROFIXATION TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT 50 MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00039.Concomitant medical products: tmj system right fossa component, small, part# 24-6562, lot# 642760a.Unknown mandible screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Initial reporter ¿patient.
 
Event Description
It was reported the patient has experienced various issues five (5) years following implantation of temporomandibular joint implants on the right side.Immediately following implantation, the patient could not raise their right eyebrow.The patient underwent eight (8) weeks of physical therapy within two (2) years of implantation and the patient could open the right side of their mouth almost as well as the left side.Five (5) years following implantation, the patient reported they are unable to open their mouth the same as it was, their right eye droops and their right eyebrow does not go up like it should.The patient reported they are able to open their mouth to eat.The patient indicated that they are satisfied with the results of their device, and will return to their surgeon should their symptoms worsen.It was reported that no further information is available.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT 50 MM / 7 HOLE
Type of Device
JOINT, TEMPOROMANDIBULAR, IMPLANT
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key11263152
MDR Text Key230219872
Report Number0001032347-2021-00040
Device Sequence Number1
Product Code LZD
UDI-Device Identifier00841036011895
UDI-Public(01)00841036011895(17)200617(10)608270
Combination Product (y/n)N
PMA/PMN Number
P020016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/25/2021
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 Date06/17/2020
Device Model NumberN/A
Device Catalogue Number01-6550
Device Lot Number608270B
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/04/2021
Initial Date FDA Received02/01/2021
Supplement Dates Manufacturer Received06/24/2021
Supplement Dates FDA Received06/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
-
-