MAUDE Adverse Event Report: BIOMET MICROFIXATION WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; JOINT, TEMPOROMANDIBULAR, IMPLANT; 50MM RIGHT NARRROW MANDIBLE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ossification (1428); Headache (1880); Nerve Damage (1979); Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of seven for the same event, reference report 0001032347-2017-00415 through 1032347-2017-00421.

Event Description

The patient reported facial pain, a worse bite and the suspicion that the screws are coming loose.The patient consented for the physician's office to release his records.The physicians notes dated (b)(6) 2017 state the patients problems began when he was about (b)(6) old of unknown etiology.His condition got progressively worse.In 2013 he had bilateral tmj total joint prosthesis.He initially did fairly well but then began developing problems and his bite began to change.He gets headaches at about a level of 6 in the temple areas.Average daily tmj pain is at a 6, average daily pain at 8, jaw function at 8, diet at 8, and disability at 8.He has no problems with earaches, tinnitus, gets moderate vertigo, but no hearing loss.No other joints bother him.He does have a history of shingles.He is aware of clenching his teeth at nighttime.He has numbness to the lower lip with it actually being a little closer to having feeling than total numbness.The frontal branch of the facial nerve has been affected, more so on the right side than the left side.He has an overbite of about 3 mm and overjet of probably around 3 mm as well.He has a class ii end-on occlusion.Maximum opening is 25 mm and he has about 1 mm translation to the right and zero to the left.The basic diagnosis would be as follows: bilateral tmj failed total joint prosthesis with loosening of bilateral mandibular components.Heterotopic bone formation around prosthesis, much greater on the left side as compared to the right side.Class ii end-on occlusion related to loosening of the prosthesis.Tmj pain.Headaches.Myofascial pain.The recommended treatment would be as follows: ct scan of jaws and jaw joints.Surgery.Removal of failed bilateral tmj prosthesis.Debridement and removal of heterotopic bone growth.Reconstruction of bilateral tmjs.Bilateral tmj fat grafts.Consider possible coronoidectomies but hopefully this will not be necessary.Application of maxillary and mandibular arch bars and skeletal stabilizing devices.Surgical stabilizing splint.

Manufacturer Narrative

The product identity was confirmed through tmj tracking.A review of the products listed in this complaint show that the implanting surgeon used four 2.7 x 10 mm high torque cross-drive screws on each side to secure the mandible component.Four screws are the minimum recommended amount for this type of fixation.However, the screws that were used are from the mandibular reconstruction system and not the total mandibular joint system.The shaft of these screws is 2.7 mm in diameter instead of the 3.2 diameter used in the tmj system.This may have contributed to the loosening of the screws, especially if the drill used to drill the pilot hole was from the tmj system and intended to be used with a screw 3.2 mm in diameter.Scans of the patient's implanted area were provided along with a physicians report.The physicians report reviews the patient's case and reports on conditions that may have contributed to the patient's current condition and also provides an overview of the scans.The physician also recommended that the "failed biomet prostheses" be replaced with a competitors product but also says that revision will be a "major medical risk".The provided scans and physician's report confirms that the screws had become displaced and the patient has malocclusion.These conditions can lead to patient discomfort; therefore, the complaint is confirmed.The most likely underlying cause of this complaint is determined to be patient condition and improper technique as described above.The non-conformance database was reviewed no non-conformance was found that would cause the event to occur.This is supplemental report two of seven for the same event; supplemental reports one through seven are reported on mfr #0001032347-2017-00415-1 through 1032347-2017-00421-1.

• Brand Name: WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT; 50MM RIGHT NARRROW MANDIBLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6593604
• MDR Text Key: 76034204
• Report Number: 0001032347-2017-00416
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

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
• Device Operator: Device Unattended
• Device Expiration Date: 06/01/2016
• Device Model Number: N/A
• Device Catalogue Number: 01-6550
• Device Lot Number: 320760B
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 08/11/2017
• Supplement Dates FDA Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other