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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN TMJ IMPLANT; JOINT, TEMPOROMANDIBULAR, IMPLANT

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BIOMET MICROFIXATION UNKNOWN TMJ IMPLANT; JOINT, TEMPOROMANDIBULAR, IMPLANT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 02/19/2024
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: foreign - united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent tmj replacement surgery on an unknown date.Approximately one year ago the implants were removed due to chronic persistent pain.A new custom implant was ordered and will be implanted at a later date.Attempts have been made and no further information has been provided.
 
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.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It was further reported that the product was removed over a year ago due to chronic and persistent post-operative pain which began immediately after the product was implanted and was relieved when the product was explanted.
 
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Brand Name
UNKNOWN TMJ IMPLANT
Type of Device
JOINT, TEMPOROMANDIBULAR, IMPLANT
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18938068
MDR Text Key338067157
Report Number0001032347-2024-00099
Device Sequence Number1
Product Code LZD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P020016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/23/2024
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 NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer Received04/04/2024
Supplement Dates FDA Received04/30/2024
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 Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age44 YR
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