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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 523191
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Test Result (2695); No Code Available (3191)
Date of Event 10/17/2013
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Ppf and medical records received.Ppf alleged elevated metal ions.After review of medical records, no revision notes reported.Doi: (b)(6) 2007; dor: (b)(6) 2013 left hip.See (b)(4) right hip.
 
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Common Device Name
S-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8552228
Report Number1818910-2019-91685
Device Sequence Number11373431
Product Code JDI
UDI-Device Identifier10603295170853
UDI-Public10603295170853
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K851422
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/05/2019
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 Expiration Date04/30/2011
Device Catalogue Number523191
Device Lot Number2142217
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/05/2019
Initial Report FDA Received Date04/25/2019
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 Age47 YR
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