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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM ASSEM UPPER PULL ROD; HIP INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS INC US RECLAIM ASSEM UPPER PULL ROD; HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 297500635
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 09/25/2017
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the assembly pull rod was mis-threaded.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Complaint description: it was reported that the assembly pull rod was mis-threaded./ | investigation method: checked display of return screen on (b)(4), not received./ | investigation summary:.
 
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Brand Name
RECLAIM ASSEM UPPER PULL ROD
Type of Device
HIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581-0988
5743725905
MDR Report Key6971415
MDR Text Key90410010
Report Number1818910-2017-27322
Device Sequence Number1
Product Code HWB
UDI-Device Identifier10603295156017
UDI-Public10603295156017
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number297500635
Device Lot NumberSO2002385
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/25/2017
Initial Date FDA Received10/24/2017
Supplement Dates Manufacturer Received11/28/2017
08/02/2018
Supplement Dates FDA Received11/29/2017
08/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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