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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT FEMORAL AUGMENT BLOCK DISTAL ONLY FEMORAL AUGMENT BLK

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ZIMMER TMT FEMORAL AUGMENT BLOCK DISTAL ONLY FEMORAL AUGMENT BLK Back to Search Results
Catalog Number 00549003624
Device Problems Unstable (1667); Material Integrity Problem (2978)
Patient Problem Failure of Implant (1924)
Event Date 09/07/2017
Event Type  Injury  
Manufacturer Narrative

Device was not returned for evaluation. A review of the implant's manufacturing record indicates that it was manufactured to specification. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. There is no indication that the augment block failed to meet specification or perform as expected. Tm femoral augment block, is the devices that was used as bone filling. Should additional information be obtained to further this investigation, this report shall be updated. Not returned by the hospital.

 
Event Description

It was reported that a patient underwent an initial knee procedure on (b)(6) 2015. The proximal portion of the offset stem extension was sheared off inside the a/p wedge implant that was in the patient. Subsequently, the patient was revised on (b)(6) 2017 due to failure of the implant. Implant failure no longer allowed the knee to be stable or functional on any level. Tm femoral augment block is the devices that was used as bone filling. This is the tmt design controlled part.

 
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Brand NameFEMORAL AUGMENT BLOCK DISTAL ONLY
Type of DeviceFEMORAL AUGMENT BLK
Manufacturer (Section D)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer (Section G)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer Contact
william hara
10 pomeroy road
parsippany, NJ 07054
9735760032
MDR Report Key7068568
MDR Text Key93286101
Report Number3005751028-2017-02743
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device Catalogue Number00549003624
Device LOT Number62468394
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/03/2013
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: 11/29/2017 Patient Sequence Number: 1
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