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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP 3DEG RT CUT BLK; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP 3DEG RT CUT BLK; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 950501225
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/26/2017
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 tibial cutting block worn stylus loose in cutting block.
 
Additional Manufacturer Narrative
The device associated with this report was not returned.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.
 
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Brand Name
SIGMA HP 3DEG RT CUT BLK
Common Device Name
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7046464
Report Number1818910-2017-29459
Device Sequence Number944921
Product Code NJL
UDI-Device Identifier10603295225300
UDI-Public10603295225300
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P830055
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) 10/26/2017
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 Number950501225
Device Lot NumberJ0908
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/26/2017
Supplement Date Received by Manufacturer11/21/2017
Initial Report FDA Received Date11/20/2017
Supplement Report FDA Received Date11/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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