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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+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 28+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 52-2028
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Date of Event 10/26/2020
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.
 
Event or Problem Description
It was reported that the patient underwent an acetabular revision and stem revision.The cup had migrated medially.The cup and liner were not depuy implants and were revised with competitor components.The stem was a 22 x 17mm calcar replacing s rom stem.The s rom sleeve was not revised and was left in the patient.A new 22 x 17mm s rom calcar body stem was implanted and a 28mm +3 ceramic head.Doi: unknown.Dor: (b)(6) 2020; affected side: right hip.
 
Additional Manufacturer Narrative
Product complaint # (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 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.Device history lot : a device history record (dhr) review, was not possible because the required lot code was not provided.
 
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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 Key10816298
Report Number1818910-2020-24301
Device Sequence Number19117078
Product Code JDI
UDI-Device Identifier10603295170792
UDI-Public10603295170792
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K920317
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/26/2020
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 Model Number52-2028
Device Catalogue Number522028
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/26/2020
Supplement Date Received by Manufacturer12/08/2020
Initial Report FDA Received Date11/10/2020
Supplement Report FDA Received Date12/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
COMPETITOR CUP; COMPETITOR LINER; SROM SLEEVE; SROM*STM STD36+21CR 22X17X165; COMPETITOR CUP; COMPETITOR LINER; SROM SLEEVE; SROM*STM STD36+21CR 22X17X165
Outcome Attributed to Adverse Event Required Intervention;
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