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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 322805
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 02/06/2019
Event Type  Injury  
Event Description
Post-op 10 months x-ray showed lock position had changed.Patient was asymptomatic.Surgeon decided to do a poly swap and found that he had not properly locked the construct.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 21204
Manufacturer Contact
110 west road
suite 227
towson, MD 21204
4104270003
MDR Report Key8400559
MDR Text Key138158480
Report Number3012104767-2019-00001
Device Sequence Number1
Product Code HSN
UDI-Device Identifier00+B0953228051
UDI-Public+B0953228051
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 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
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 Number322805
Device Catalogue Number322805
Device Lot NumberAAAJK
Was Device Available for Evaluation? No
Date Manufacturer Received02/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2018
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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