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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DT MEDTECH, LLC HINTERMANN SERIES H2 TIBIAL ASSEMBLY; ANKLE, TIBIAL COMPONENT
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DT MEDTECH, LLC HINTERMANN SERIES H2 TIBIAL ASSEMBLY; ANKLE, TIBIAL COMPONENT Back to Search Results
Model Number 321804
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 06/03/2020
Event Type  Injury  
Event Description
Post-op 22 months x-ray showed lock position had changed.On (b)(6), dt medtech was made aware of a planned revision.Surgeon performed the revision on (b)(6) 2020 and found that the locking arms were broken.Surgery was successful.Patient post-op asymptomatic.
 
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Brand Name
HINTERMANN SERIES H2 TIBIAL ASSEMBLY
Type of Device
ANKLE, TIBIAL COMPONENT
Manufacturer (Section D)
DT MEDTECH, LLC
110 west road
suite 227
towson, md
Manufacturer Contact
110 west road
suite 227
towson, md 
4270003
MDR Report Key10222331
MDR Text Key197572377
Report Number3012104767-2020-00001
Device Sequence Number1
Product Code HSN
UDI-Device Identifier+B095321804
UDI-Public+B095321804
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/28/2022
Device Model Number321804
Device Catalogue Number321804
Device Lot NumberAAAJC
Was Device Available for Evaluation? No
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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