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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 14/16 LG TAPER M HEAD 36MM+5; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
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DEPUY INT'L LTD. 8010379 14/16 LG TAPER M HEAD 36MM+5; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 101836505
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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
Ppf and sticker sheets received.In addition to what were previously alleged, ppf alleges dislocation.
 
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Brand Name
14/16 LG TAPER M HEAD 36MM+5
Common Device Name
LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK  LS11 8 DT
MDR Report Key8122076
Report Number1818910-2018-76853
Device Sequence Number1693610
Product Code JDI
UDI-Device Identifier10603295001386
UDI-Public10603295001386
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
K120599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number101836505
Device Lot Number8157648
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/06/2018
Initial Report FDA Received Date12/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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