MAUDE Adverse Event Report: ZIMMER TMT TM CUP-CAGE

Catalog Number UNKNOWN

Device Problem Device Inoperable (1663)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported in a journal article, that a patient who was implanted with a tm cup-cage construct exhibited radiological failure with worsening pain and function but had not agreed to revision at the time of presenting the study.No further information was provided.

Manufacturer Narrative

Investigation is in progress.

• Brand Name: TM CUP-CAGE
• Type of Device: TM CUP-CAGE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy rd.; parsippany NJ 07054
• Manufacturer Contact: anand singh ; 10 pomeroy rd.; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 4185995
• MDR Text Key: 5026858
• Report Number: 3005751028-2014-00073
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2014
• 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