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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M 28MM 5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US ARTICULEZE M 28MM 5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136512500
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Joint Dislocation (2374); No Code Available (3191)
Date of Event 01/16/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).For the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Ppf and implant record received.Implant records reported that the patient underwent closed reduction converted to open.Doi: (b)(6) 2016; dor: (b)(6) 2017, (right hip) fourth revision.
 
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Brand Name
ARTICULEZE M 28MM 5
Common Device Name
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8826081
Report Number1818910-2019-99198
Device Sequence Number19505017
Product Code JDI
UDI-Device Identifier10603295033097
UDI-Public10603295033097
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K843909
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/08/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date08/30/2021
Device Catalogue Number136512500
Device Lot Number8351337
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/08/2019
Initial Report FDA Received Date07/25/2019
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 Age60 YR
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