MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 7 MM; BONE SCREW

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation tmj system right narrow mandibular component, catalog #: 01-6545, lot #:584410b; biomet microfixation tmj system right fossa component, small, catalog #: 24-6562, lot #:578180b; biomet microfixation "2.4 mm" system high torque (ht) cross-drive screw 2.7 x 8mm, catalog #: 91-2708, lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2018-00712, 0001032347-2018-00713, and 0001032347-2018-00714.

Event Description

It was reported there was a revision due to dislocation.The right side implants were removed and replaced with new biomet microfixation tmj implants.No additional patient consequences were reported.

Manufacturer Narrative

Because the implants were explanted in a revision surgery, the complaint is considered confirmed.The product identity was confirmed through tmj tracking.The distributor originally stated that a bilateral explant took place, however, tracking cards were only received for the implants from the right side.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 device history record (dhr) was reviewed for the mandible component and no discrepancies were found.There were no non-conformances found for the fossa component.The dhr's for the screws could not be reviewed due to the lot numbers being unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The instructions for use (ifu) for this product warns of the potential for complications.It states in the section titled adverse events: ¿ dislocation it also states in the section titled patient counseling information: discussion of the following points is recommended prior to surgery.¿ the risks associated with a total tmj system (see warnings and adverse events).¿ post-operative pain relief and return of function varies from patient to patient.¿ additional treatment may be required including but not limited to extended physical therapy, bite splint, dental braces, and/or orthognathic and reconstructive surgery.There are no indications of manufacturing defects.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: 0001032347-2018-00712-1, 0001032347-2018-00713-1, and 0001032347-2018-00714-1.

Event Description

This follow-up report is being submitted to relay corrected and additional information.It was reported the reason for the dislocation was due to possible non-compliance and patient anatomy.

• Brand Name: TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 7 MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8010950
• MDR Text Key: 125194711
• Report Number: 0001032347-2018-00715
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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 Number: N/A
• Device Catalogue Number: 99-6577
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention