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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SM LFT FOSSA COMP; JOINT, TEMPOROMANDIBULAR, IMPLANT

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BIOMET MICROFIXATION TMJ SM LFT FOSSA COMP; JOINT, TEMPOROMANDIBULAR, IMPLANT Back to Search Results
Model Number N/A
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)
Event Date 05/08/2023
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4) d10 ¿ medical products: item# ni, lot# ni; unk tmj system left mandibular component.G2: consumer: patient.The device will not be returned for analysis; 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: 0001032347-2023-00135.
 
Event Description
It is reported that the patient¿s revision procedure was planned due to dislocation and infection.However, no revision procedure has been reported to date.
 
Event Description
No further event information available at the time of this report.
 
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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that a patient underwent a revision procedure approximately 14 months post implantation due to dislocation and infection.Attempts have been made and no further event information is available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of the device history records identified no deviations or anomalies during manufacturing.The sterile certificates were reviewed and noted to be conforming.The parts were sterilized in accordance with fda regulations and iso standards.A definitive root cause cannot be determined.The reported event is unconfirmed.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
No further event information is available at the time of this report.
 
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Brand Name
TMJ SM LFT FOSSA COMP
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 Key16764635
MDR Text Key313532515
Report Number0001032347-2023-00134
Device Sequence Number1
Product Code LZD
UDI-Device Identifier00841036036584
UDI-Public(01)00841036036584(17)261001(10)071870A
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 11/01/2023
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number24-6563
Device Lot Number071670A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/20/2023
Initial Date FDA Received04/18/2023
Supplement Dates Manufacturer Received05/01/2023
05/25/2023
10/30/2023
Supplement Dates FDA Received05/26/2023
06/21/2023
11/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2021
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
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age48 YR
Patient SexFemale
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