MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Headache (1880); Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as it remains implanted in the patient; 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: 0001032347-2020-00088, 0001032347-2020-00090, 0001032347-2020-00091, 0001032347-2020-00092, 0001032347-2020-00093, 0001032347-2020-00094, 0001032347-2020-00095.Medical products: tmj system right standard mandibular component, part# 24-6545, lot# 183570, tmj system left standard mandibular component, part# 24-6546, lot# 174120, tmj system right fossa component, small, part# 24-6562, lot# 216350, tmj system left fossa component, small, part# 24-6563, lot# 190720, 2.4mm system high torque (ht) cross-drive screw, part# 91-2708, lot# unk, 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, tmj system cross drive fossa screw, part# 99-6579, lot# unk, tmj system cross drive fossa screw, part# 99-6581, lot# unk.Occupation: patient.

Event Description

It was reported the patient underwent a revision surgery due to heterotopic bone growth and dislocation involving bilateral temporomandibular joint prostheses.The patient was received stock implants over a decade ago, and currently reports limited range of motion, headaches, pain and swelling.Fifteen months ago, the patient reported heterotopic ossification in the joint and implant dislocation on the right side.Thirteen months ago, the patient reported a revision surgery in which the existing implants were re-positioned.Trigger point injections and nerve blocks have been inadequate regarding pain management.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed as a revision surgery was reported to address the bone overgrowth and dislocation.No product was returned; therefore, no functional tests or inspections could be conducted.No scans or physician's reports were provided.The non-conformance database was reviewed for the mandible component; no non-conformances were found.There are no indications of manufacturing defects.There were 4 complaints for this part# 24-6546, lot# 174120, including this complaint.The other three were previous complaints from the same patient.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, there is a complaint rate of 0.36%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding dislocation, there is a complaint rate of 0.39%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding limited range of motion leading to a revision, there is a complaint rate of 0.08%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding bone growth, there is a complaint rate of 0.24%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding infection, there is a complaint rate of 0.28%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding allergic reaction, there is a complaint rate of 0.36%, which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the bone growth is due to patient condition.It was reported that this bone growth was the cause of the dislocation.It could not be determined from the information provided if the limited range of motion and pain were related to the bone growth and dislocation, or if they were separate issues.The root causes of the reported possible allergic reaction to titanium and infection could not 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: b4 date of this report.B5 describe event or problem.D4 expiration date.D10 device availability.G4 date received by manufacturer.G7 type of report.H2 follow up type.H3 device evaluated by manufacturer.H6 method code.H6 results code.H6 conclusions code.H10 additional narratives/data.

Event Description

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

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9677217
• MDR Text Key: 178001557
• Report Number: 0001032347-2020-00089
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036454
• UDI-Public: 00841036036454
• 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
• Report Date: 07/27/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2011
• Device Model Number: N/A
• Device Catalogue Number: 24-6546
• Device Lot Number: 174120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/27/2020
• 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; Disability