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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.181898910 LCS HP FEM NOTCH IMPACTOR; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC.181898910 LCS HP FEM NOTCH IMPACTOR; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 950501219
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/23/2017
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 impacting head has broken off the impacting base.
 
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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.
 
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Brand Name
LCS HP FEM NOTCH IMPACTOR
Common Device Name
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.181898910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7047939
Report Number1818910-2017-29480
Device Sequence Number19195171
Product Code HWA
UDI-Device Identifier10603295225263
UDI-Public10603295225263
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 10/25/2017
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
Operator of Device Health Professional
Device Catalogue Number950501219
Device Lot NumberPG0209
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/25/2017
Supplement Date Received by Manufacturer12/11/2017
Initial Report FDA Received Date11/21/2017
Supplement Report FDA Received Date12/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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