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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 28+3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 28+3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 875953
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Joint Dislocation (2374); No Code Available (3191)
Date of Event 11/12/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event or Problem Description
It was reported that the head was revised today as the competitors dual mobility construct continuously dislocated.Doi: (b)(6) 2019.Dor: (b)(6) 2019; right hip.
 
Additional Manufacturer Narrative
Report # 1818910-2019-120892 is being retracted since the complaint was determined to involve a non-depuy device.There is no report of an adverse event involving a depuy device.
 
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Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key9417734
Report Number1818910-2019-120892
Device Sequence Number11190423
Product Code JDI
UDI-Device Identifier10603295218838
UDI-Public10603295218838
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K920317
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/12/2019
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 Number875953
Device Lot Number8847058
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/12/2019
Supplement Date Received by Manufacturer01/10/2020
Initial Report FDA Received Date12/05/2019
Supplement Report FDA Received Date01/10/2020
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;
Patient Age66 YR
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