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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMORAL COCR 32+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMORAL COCR 32+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 522032
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Tissue Damage (2104); Joint Dislocation (2374); Test Result (2695)
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.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
Litigation alleges pseudotumor, dislocation with closed reduction, and elevated metal ions after first revision.
 
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Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8117001
Report Number1818910-2018-76673
Device Sequence Number11175962
Product Code JDI
UDI-Device Identifier10603295170822
UDI-Public10603295170822
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K920317
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/05/2018
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 Number522032
Device Lot Number3372125
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/05/2018
Initial Report FDA Received Date11/29/2018
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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