MAUDE Adverse Event Report: ZIMMER TRABECULAR METAL TECHNOLOGY TM 500 GENERIC

Device Problem Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 10/24/2014

Event Type  Injury  

Event Description

It was reported that after three months, a patient returned to the doctor with back pain; it seems the listhesis was still progressive, non-fusion of the plif cages.

Manufacturer Narrative

Investigation is in progress.

• Brand Name: TM 500 GENERIC
• Type of Device: TM 500
• Manufacturer (Section D): ZIMMER TRABECULAR METAL TECHNOLOGY; 10 pomeroy rd.; parsippany NJ 07054
• Manufacturer Contact: anand singh ; 10 pomeroy rd.; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 4301356
• MDR Text Key: 5191042
• Report Number: 3005751028-2014-00103
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/24/2014
• 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
• Patient Outcome(s): Required Intervention