MAUDE Adverse Event Report: BIOMET MICROFIXATION WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; JOINT, TEMPOROMANDIBULAR, IMPLANT; TMJ SMALL LEFT FOSSA

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Without a product return no product evaluation is able to be conducted.No x-rays, scans, pictures, or physician's reports were provided.Based on the information available the most likely cause of the screws backing out is the patient's condition.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.This is report two of seven for the same event; reference reports 0001032347-2017-00716 through 0001032347-2017-00722.

Event Description

A tmj revision was performed due to changes in the patient's anatomy.It was reported the patient's bone eroded resulting in the screws backing out.All parts were removed and replaced with new implants that better fit the changes in the patient's anatomy.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.These parts were removed in a revision; therefore the complaint is considered confirmed.The distributor reported that due to the screws backing out as a result of the patient's bone eroding, the implants were replaced with ones that better fit the change in the patients anatomy.The distributor stated there will be no return for this file as he believes the parts were discarded.The manufacturing history was reviewed and no non-conformance was identified.Review of the complaint history determined that no further action is required as no trends were identified.Investigation results concluded that the reported event was due to the patient's condition.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.The following sections were updated: date of this report, date received by manufacturer, type of report and follow-up number, follow-up type, device evaluated by manufacturer and not returned to manufacturer, multiple mdr reports were filed for this event, please see associated reports: 0001032347-2017-00716-1 through 0001032347-2017-00722-1.

• Brand Name: WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT; TMJ SMALL LEFT FOSSA
• 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: 6863309
• MDR Text Key: 86077601
• Report Number: 0001032347-2017-00717
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

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: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 405150A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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): Hospitalization; Required Intervention