MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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, 0001032347-2021-00074, 0001032347-2021-00075.Date of event was reported to be (b)(6) 2020 or (b)(6) 2020.Explantation date was reported to be (b)(6) 2020 or (b)(6) 2020.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot# 503520b; unknown mandible screw, part# ni, lot# ni; unknown fossa screw, part# ni, lot# ni.Initial reporter ¿ patient¿s mother.
Event or Problem 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.
Additional 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, 0001032347-2021-00074, 0001032347-2021-00075, 0001032347-2021-00141, 0001032347-2021-00142, 0001032347-2021-00143.D10 ¿ medical products tmj system left fossa component, small, part# 24-6563, lot# 503520b 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, unknown fossa 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.
Event or Problem 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.

• Brand Name: TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11344855
• Report Number: 0001032347-2021-00073
• Device Sequence Number: 5035689
• Product Code: LZD
• UDI-Device Identifier: 00841036064884
• UDI-Public: (01)00841036064884(17)181201(10)502310
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 24-6651
• Device Lot Number: 502310A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 19 YR