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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW; BONE SCREW
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BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW; BONE SCREW Back to Search Results
Model Number N/A
Device Problems Biofilm coating in Device (1062); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Swelling (2091)
Event Date 11/26/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Medical product: biomet microfixation custom made device george pm-tmj & model catalog #: tmjpm-1887 lot #: 798940a, biomet microfixation "2.4mm" system ht cross-drive screw catalog #: 91-2710 lot #: ni, biomet microfixation "2.4mm" system ht cross-drive screw catalog #: 91-2712 lot #: ni, biomet microfixation "2.4mm" system ht cross-drive screw catalog #: 91-2716 lot #: ni, biomet microfixation "2.4mm" system ht cross-drive screw catalog #: 91-2718 lot #: ni, biomet microfixation tmj system cross drive fossa screw catalog #: 99-6577 lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the devices remain implanted.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: 0001032347-2018-00331, 0001032347-2018-00332, 0001032347-2018-00333, 0001032347-2018-00334, 0001032347-2018-00335, and 0001032347-2018-00336.
 
Event Description
It was reported the patient had a biopsy of the tmj.The surgeon reported "the culture results were negative other than a few pmn¿s (polymorphonuclear leukocytes) from one of the three sites biopsied.The surgical path was also negative.This was done to rule out pji (periprosthetic joint infection) and biofilm due to a three month history of intermittent left facial swelling that resolves with antibiotics." the onset of symptoms started approximately three months after implantation.No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00331-1, 0001032347-2018-00332-1, 0001032347-2018-00333-1, 0001032347-2018-00334-1, 0001032347-2018-00335-1, and 0001032347-2018-00336-1.
 
Event Description
It was additionally reported the surgeon requested information regarding new implants for the patient.He stated the patient has an infection and "biofilm" and that he plans to remove the implants and place spacers, treat the patient with antibiotics for six weeks, wait an additional two weeks to ensure the infection is cleared, then implant new prosthesis.The removal is not yet scheduled and will not be scheduled until a timeline is established for the approval and manufacture of the new prosthesis.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00331-3, 0001032347-2018-00332-3, 0001032347-2018-00333-3, 0001032347-2018-00334-3, 0001032347-2018-00335-3, and 0001032347-2018-00336-3.
 
Event Description
It was reported the removal did take place.The sales representative stated there were no issues during the revision to his knowledge.The surgeon plans to send the joint back to the manufacturer once the hospital completes their prolonged culture in their lab.They estimated it would be ready to ship back in three (3) weeks.
 
Event Description
This follow-up report is being submitted to relay additional information.
 
Manufacturer Narrative
This follow-up is being submitted to relay additional information.Reported event was confirmed by evidence that the revision was performed.These parts were removed in a revision due to infection; therefore the complaint is considered confirmed.No x-rays, scans, pictures, or physicians reports were provided.No details were provided as to the cause of the infection.All tmjpms are distributed sterile.The sterile certifications for this product were reviewed and no anomalies were found.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Returned product was visually inspected and no anomalies were observed.For these reasons, the root cause was unable to be determined.There is no evidence to suggest that the cause of the infection is implant related.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00331-4, 0001032347-2018-00332-4, 0001032347-2018-00333-4, 0001032347-2018-00334-4, 0001032347-2018-00335-4, 0001032347-2018-00336-4.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was reported the patient developed an infection and "biofilm" around the joint; therefore the complaint is considered confirmed.No product was returned and no inspections could be performed.No x-rays, scans, pictures, or physicians reports were provided.No details were provided as to the cause of the infection.All tmjpms are distributed sterile.Device history record (dhr) and sterile certs of the tmj-pm were reviewed and no discrepancies were found.Device history record (dhr) review was unable to be performed for the screws as the lot number of the devices involved in the event is unknown.There are no indications of manufacturing defects.For these reasons, the most likely underlying cause of this complaint could not be determined.There is no evidence to suggest that the cause of the infection is implant related.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00331-2, 0001032347-2018-00332-2, 0001032347-2018-00333-2, 0001032347-2018-00334-2, 0001032347-2018-00335-2, and 0001032347-2018-00336-2.
 
Event Description
This report is being submitted to document the completion of the investigation.
 
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Brand Name
TMJ SYSTEM CROSS DRIVE FOSSA SCREW
Type of Device
BONE SCREW
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key7560463
MDR Text Key109772353
Report Number0001032347-2018-00337
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
PMA/PMN Number
PK910038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number99-6579
Device Lot NumberUNKNOWN
Other Device ID Number(01)00841036057459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2019
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age53 YR
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