MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN FOSSA SCREW; PLATE, BONE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; 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: 0001032347-2021-00072, 0001032347-2021-00073, 0001032347-2021-00074.Date of event was reported to be (b)(6) 2020.Explantation date was reported to be (b)(6) 2020.Medical products tmj system left fossa component, small, part# 24-6563, lot# 503520b.Tmj system left standard offset mandibular component 50mm / 9 hole, part# 24-6651, lot# 502310a.Unknown mandible screw, part# ni, lot# ni.Patient¿s mother.

Event Description

It was reported the patient underwent a revision to remove temporomandibular joint implants on the left side due to infection and loosening.Seven (7) years following implantation, the patient went to urgent care and pus pockets were found around the area of the devices.The patient was transferred to a hospital and it was discovered that screws were loose in the bottom implant.The surgeon reportedly believed that the devices were rubbing and caused the infection.The patient was prescribed antibiotics for one (1) month following the explantation.It is planned that the patient will receive new custom devices in three (3) months.No additional patient consequences have been reported.

Event Description

It was reported the patient underwent a revision to remove temporomandibular joint implants on the left side due to infection and loosening.Seven (7) years following implantation, the patient went to urgent care and pus pockets were found around the area of the devices.The patient was transferred to a hospital and the devices were explanted.It was found that the left temporomandibular joint implant failed at its attachment to the ramus of the mandible and all four (4) screws that had been attached to the native body/ramus were floating.There was an open wound in the mouth and this was likely the source of the infection.The surgeon reportedly believed that the devices were rubbing and caused the infection.The patient was prescribed antibiotics for one (1) month following the explantation.It is planned that the patient will receive new custom devices in three (3) months.It was reported that no further information is available.

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: 0001032347-2021-00072, 0001032347-2021-00073, 0001032347-2021-00074, 0001032347-2021-00141, 0001032347-2021-00142, 0001032347-2021-00143.D10 ¿ medical products: tmj system left fossa component, small, part# 24-6563, lot# 503520b.Tmj system left standard offset mandibular component 50mm / 9 hole, part# 24-6651, lot# 502310a.Unknown mandible screw, part# ni, lot# ni, unknown mandible screw, part# ni, lot# ni, unknown mandible screw, part# ni, lot# ni, unknown mandible screw, part# ni, lot# ni.This report is being submitted to update additional information in section b3, b5, b7, d6b, d10, e1, e2, e3, g2, h2, h6 and h10.

• Brand Name: UNKNOWN FOSSA SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11344872
• MDR Text Key: 241443639
• Report Number: 0001032347-2021-00075
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR