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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 32MM +6; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 32MM +6; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 136532230
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Joint Dislocation (2374); No Code Available (3191)
Date of Event 12/30/2013
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.Initial reporter is a non-healthcare professional.(b)(4).
 
Event or Problem Description
Litigation alleges dislocation with closed reduction.Doi: (b)(6) 2013.Dor: (b)(6) 2014 (left hip).
 
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Brand Name
DELTA CER HEAD 11/13 32MM +6
Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8499700
Report Number1818910-2019-90298
Device Sequence Number19304000
Product Code LZO
UDI-Device Identifier10603295033424
UDI-Public10603295033424
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K031803
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2014
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/20/2019
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 Number136532230
Device Lot Number3619067
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/20/2019
Initial Report FDA Received Date04/10/2019
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 Age65 YR
Patient Weight65
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