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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20F SML; HIP INSTRUMENTS : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20F SML; HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Catalog Number 257620120
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/19/2018
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that the sleeve is worn out very badly and will not seat on insertion instrument.
 
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Brand Name
ZT TRIAL SLEEVE 20F SML
Common Device Name
HIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8245825
Report Number1818910-2019-80854
Device Sequence Number16630934
Product Code LXH
UDI-Device Identifier10603295146773
UDI-Public10603295146773
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
Report Date (Section B) 01/04/2019
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 Number257620120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/04/2019
Initial Report FDA Received Date01/14/2019
Patient Sequence Number1
Patient Age47 YR
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