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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ZT TRIAL SLEEVE 16D LRG; HIP INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910 ZT TRIAL SLEEVE 16D LRG; HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 257616115
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/22/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that upon post-surgical inspection of instrument pans, it was discovered that some of the sleeves were chipped away to where debris could be a concern during trialing.
 
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ZT TRIAL SLEEVE 16D LRG
Common Device Name
HIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key6731273
Report Number1818910-2017-21454
Device Sequence Number1243826
Product Code LXH
UDI-Device Identifier10603295146452
UDI-Public10603295146452
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/22/2017
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
Operator of Device Health Professional
Device Catalogue Number257616115
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2017
Initial Date Received by Manufacturer 06/22/2017
Supplement Date Received by Manufacturer08/21/2017
Initial Report FDA Received Date07/21/2017
Supplement Report FDA Received Date08/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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