MAUDE Adverse Event Report: NEXUS CMF PATIENT-SPECIFIC TMJ FOSSA-EMINENCE PROSTHESIS; NONE

Model Number 500105

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Swelling (2091); Arthralgia (2355)

Event Date 04/07/2015

Event Type  Injury  

Manufacturer Narrative

Five screws were also explanted with the left fossa eminence prosthesis on (b)(6) 2015.Screws: model number 500094, lot 16520, lot 16521, lot 16718; screws: model number 500095, lot 15801, lot 16661; and screws: model number 500097, lot 15792.

Event Description

On (b)(6) 2014 the patient had a left total temporomandibular joint replacement consisting of both fossa and condylar implants.In (b)(6) of 2015 the patients left temporomandibular joint began swelling.The swelling increasingly worsened up to the date when the left fossa implant and screws were explanted on (b)(6) 2015.During the explant procedure it was observed that the fossa eminence prosthesis was displaced 7mm within the joint and screws had become loose.The most anterior two screws were loose and the most anterior screw had backed out by two to three thread turns.Debridement of the joint space was also performed during the explant surgery to remove fibrosis and cartilaginous material.

• Brand Name: PATIENT-SPECIFIC TMJ FOSSA-EMINENCE PROSTHESIS
• Type of Device: NONE
• Manufacturer (Section D): NEXUS CMF; golden CO
• Manufacturer Contact: 17301 w colfax ave ste 170; golden, CO 80401-4800
• MDR Report Key: 5165670
• MDR Text Key: 28907529
• Report Number: 3009702671-2015-00002
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2015

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: No Information
• Device Expiration Date: 05/30/2019
• Device Model Number: 500105
• Device Lot Number: 17533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1