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U.S. Department of Health and Human Services

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

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ZIMMER TMT TRABECULAR METAL POSTERIOR FEMORAL AUGMENT BLOCK TM POSTERIOR FEMORAL AUGMENT Back to Search Results
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.

 
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Brand NameTRABECULAR METAL POSTERIOR FEMORAL AUGMENT BLOCK
Type of DeviceTM 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 Key5225814
MDR Text Key31313577
Report Number3005751028-2015-00164
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK040487
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received11/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2018
Device MODEL NumberN/A
Device Catalogue Number00549003601
Device LOT Number62259146
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 11/16/2015 Patient Sequence Number: 1
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