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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRIAL SPACER 12/14 -3 HIP INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS INC US TRIAL SPACER 12/14 -3 HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 203816000
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
(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 -3 tapered trial was broken with neck trial stuck inside.
 
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 -3 tapered trial was broken with neck trial stuck inside.
 
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Brand NameTRIAL SPACER 12/14 -3
Type of DeviceHIP 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 Key6821728
MDR Text Key117761944
Report Number1818910-2017-23536
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295084327
UDI-Public10603295084327
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
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number203816000
Device Lot NumberHT0208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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