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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SP*2 FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS
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DEPUY ORTHOPAEDICS, INC. 1818910 SP*2 FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS Back to Search Results
Catalog Number 966180
Device Problems Dull, Blunt (2407); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Wellington hospital (b)(6) 2018.After use on patient: pfc femoral impactor inspected and screws are loose.Although these can be tightened it appears these screws have become too worn for this to be an effective measure.
 
Manufacturer Narrative
The device associated with this report was not returned for evaluation.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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Type of Device
KNEE INSTRUMENT : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7442639
MDR Text Key105898275
Report Number1818910-2018-57755
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295247203
UDI-Public10603295247203
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number966180
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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