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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRLC SCR TRL LN NEUT 28ID 48OD; HIP INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS INC US DRLC SCR TRL LN NEUT 28ID 48OD; HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 223708000
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 07/19/2017
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 the screws are broken out of trial.Surgeons are complaining.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
DRLC SCR TRL LN NEUT 28ID 48OD
Common Device Name
HIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key6801560
Report Number1818910-2017-22989
Device Sequence Number1247859
Product Code LXH
UDI-Device Identifier10603295106593
UDI-Public10603295106593
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/19/2017
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 Number223708000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/19/2017
Supplement Date Received by Manufacturer07/27/2018
Initial Report FDA Received Date08/17/2017
Supplement Report FDA Received Date07/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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