MAUDE Adverse Event Report: ZIMMER BIOMET TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; TMJ MEDIUM RIGHT FOSSA COMP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Joint Dislocation (2374)

Event Date 03/18/2006

Event Type  Injury  

Manufacturer Narrative

The devices were returned and analyzed as part of the (b)(4) study.This is late information received from the (b)(4), which was reported as expected to the ps studies program, but inadvertently not recognized as 803 reportable until after the close of the study.Report 1032347-2006-00007 was submitted for this event, however there are two explanted devices.The possible mode of failure: clinical and mechanical evidence suggests twisting of the explanted fossa verified at the time of surgery and possibly a result of the mal-articulation of the head of the condyle to the medial articular surface that led to the dislocation, resulting in failure of the device.The probable cause of failure: clinical and mechanical data suggest a revision surgery due to technique failure, related to incorrect placement of the device.The device had been implanted for 2 weeks when dislocated.Report two of two for the same event, reference 1032347-2006-00007.

Event Description

A revision due to dislocation of the prostheses was reported.

• Brand Name: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: TMJ MEDIUM RIGHT FOSSA COMP
• Manufacturer (Section D): ZIMMER BIOMET; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): ZIMMER BIOMET; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5685606
• MDR Text Key: 46109243
• Report Number: 0001032347-2016-00244
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2006

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: 04/01/2009
• Device Model Number: N/A
• Device Catalogue Number: 24-6560
• Device Lot Number: 510350
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2006
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2006
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2004
• 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