MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION CUSTOM BILATERAL TOTAL TEMPOROMANDIBULAR JOINT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age: it was reported the patient is 50ish.(b)(6).This product is manufactured by zimmer biomet and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet manufactures a similar device that is cleared or distributed in the united states under pma number p020016.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported an exploratory procedure was performed due to the patient experiencing pain.A biomet custom bilateral total temporomandibular joint was implanted two years ago, with a good result and the patient was happy and had no issues.The surgeon reports there was no change in function at one year and the maximum opening circa 20 mm.During the exploratory procedure the surgeon opened to explore fossa, he reports it was rock solid, no infection fluid, hyperaemia or anything, the plastic appears intact,and all screws are tight; therefore nothing was removed.No cause for the patient's pain was identified.Based on a review of the ct scan prior to the procedure, it was thought the fossa was only secured with three screws, which may not give the implant enough support.It was confirmed the fossa has five screws, not three.The part and lot information is unknown at this time, attempts have been made and no further information has been provided.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint that the patient is having pain is considered confirmed because this resulted in the surgeon performing exploratory surgery.The surgeon reports during his exploratory surgery of the patient, he did not note fluid to indicate infection; the implant appeared intact; the fossa had five (5) screws (and not three (3)) that were tightly fixated and that he did not remove anything.The surgeon indicated no cause of the pain was found and the implants remain implanted.Product identity could not be confirmed due to the products not being returned.Device history record (dhr) review was unable to be performed as the part numbers and lot numbers of the devices involved in the event are unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOMET MICROFIXATION CUSTOM BILATERAL TOTAL TEMPOROMANDIBULAR JOINT
• Type of Device: TOTAL TEMPOROMANDIBULAR JOINT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7275686
• MDR Text Key: 100235814
• Report Number: 0001032347-2018-00083
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR