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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS
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DEPUY ORTHOPAEDICS INC US HP FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS Back to Search Results
Catalog Number 226777000
Medical Device Problem Code Scratched Material (3020)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.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
Impactor became scuffed.
 
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Brand Name
HP FEMORAL IMPACTOR
Common Device Name
KNEE INSTRUMENT : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8252238
Report Number1818910-2019-81037
Device Sequence Number13984495
Product Code HWA
UDI-Device Identifier10603295108948
UDI-Public10603295108948
Combination Product (Y/N)N
Initial Reporter StateNJ
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) 12/20/2018
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 Number226777000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/20/2018
Initial Report FDA Received Date01/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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