MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Feeding Problem (1850); Pain (1994); Inadequate Pain Relief (2388); Difficulty Chewing (2670)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint cmp-(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: 0001032347-2020-00155.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.Occupation - patient.
Event or Problem 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 or Problem Description
It was initially reported that the patient would undergo a revision to remove temporomandibular joint implants on the right side.Additional information was received that indicated while the fossa component would be removed, the mandible component would not be revised.There is no indication of a device problem with the mandible component, and it will not be removed in a revision.Therefore, the mandible component no longer meets the criteria of a reportable event.

• Brand Name: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9813414
• Report Number: 0001032347-2020-00154
• Device Sequence Number: 3002250
• Product Code: LZD
• UDI-Device Identifier: 00841036036430
• UDI-Public: 00841036036430
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-6545
• Device Lot Number: 024930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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