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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT

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BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00207, 0001032347-2020-00208, 0001032347-2020-00210, 0001032347-2020-00211, 0001032347-2020-00212.Medical products: tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 535280a.Tmj system left standard mandibular component 45mm / 7 hole, part# 24-6546, lot# 567720a.Tmj system right fossa component, small, part# 24-6562, lot# 503450a.Tmj system left fossa component, small, part# 24-6563, lot# 501530a.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Occupation: patient.
 
Event Description
It was reported by the patient that a revision may occur following implantation of bilateral temporomandibular joint implants five (5) years ago due to pain and limited range of motion.No additional patient consequences have been reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The non-conformance database was reviewed and there were no non-conformances were found.There are no indications of manufacturing defects.There have been 3 complaints for this item# 24-6562, lot# 503450a.The other 2 are the previous reports from this patient.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain leading to a revision, there is a complaint rate of 0.47%, which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding limited range of motion leading to a revision, there is a complaint rate of 0.21%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not 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
This follow-up report is being submitted to relay additional information.
 
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Brand Name
TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
Type of Device
JOINT, TEMPOROMANDIBULAR, IMPLANT
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key9949700
MDR Text Key194203376
Report Number0001032347-2020-00209
Device Sequence Number1
Product Code LZD
UDI-Device Identifier00841036036560
UDI-Public00841036036560
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 09/10/2020
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 Date12/01/2018
Device Model NumberN/A
Device Catalogue Number24-6562
Device Lot Number503450A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/25/2020
Initial Date FDA Received04/10/2020
Supplement Dates Manufacturer Received09/08/2020
Supplement Dates FDA Received09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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