MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problems Feeding Problem (1850); Pain (1994); Inadequate Pain Relief (2388); Difficulty Chewing (2670)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: 0001032347-2020-00154.Concomitant medical products: tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 024930.Tmj system right fossa component, small, part# 24-6562, lot# 284560.Unknown screws, part# unk, lot# unk.Initial reporter - patient.

Event Description

It was reported the patient has experienced pain, inadequate relief of pain, difficulty chewing and difficulty eating following implantation of bilateral temporomandibular joint implants thirteen years ago.Four months ago, the patient reported a cat scan was performed that revealed two screws on the right side were not intact and not stable.There is a revision planned to remove the implants on the right side and fat grafts will be placed in the joint.No additional patient consequences have been reported.

Event Description

It was reported the patient has experienced pain, inadequate relief of pain, difficulty chewing and difficulty eating following implantation of bilateral temporomandibular joint implants thirteen years ago.The patient reported a cat scan was performed that revealed two screws on the right side were not intact and not stable.There is a revision planned to remove the implants on the right side and fat grafts will be placed in the joint.Additional information was received that indicated the mandible component would not be revised and only the fossa component would be removed in a revision.The revision is planned but has not been scheduled.No additional patient consequences have been reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed, because of the additional follow up treatment mentioned and there is a plan for revision surgery.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 non-conformance database was reviewed for the fossa component; no non-conformances were found.There are no indications of manufacturing defects.There are 9 complaints for this part# 24-6562, lot# 284560.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding nerve damage, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding difficulty chewing leading to a revision surgery, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date), there have been 3 similar complaints (4 parts total) of screws not being intact (including this complaint).There have been 1892 non-custom tmj fossa implants shipped in the last year (from the notification date).This leads to a complaint rate of (b)(4), which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined.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.The following fields were updated: date of this report; describe event or problem; expiration date; device availability; date received by manufacturer; type of report; follow up type; device evaluated by manufacturer; method code; results code; conclusions code; additional narratives/data.

• Brand Name: TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9813428
• MDR Text Key: 195810643
• Report Number: 0001032347-2020-00155
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036560
• UDI-Public: 00841036036560
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2012
• Device Model Number: N/A
• Device Catalogue Number: 24-6562
• Device Lot Number: 284560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention