MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL POSTERIOR FEMORAL AUGMENT BLOCK; TM POSTERIOR FEMORAL AUGMENT

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

Event Description

It was reported that the patient is experiencing pain and possible allergic reaction.The patient was implanted with tm augments on (b)(6) 2013 but as of this notification has not been revised of these components.

• Brand Name: TRABECULAR METAL POSTERIOR FEMORAL AUGMENT BLOCK
• Type of Device: TM POSTERIOR FEMORAL AUGMENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: anand singh ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 5225814
• MDR Text Key: 31313577
• Report Number: 3005751028-2015-00164
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040487
• 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
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00549003601
• Device Lot Number: 62259146
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other