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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-36-310
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577)
Event Date 02/15/2021
Event Type  Injury  
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 Description

Revision pinnacle metal liner because of metalosis. The head has been revised as well.

 
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Brand NameDELTA CER HEAD 12/14 36MM +1.5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11527662
MDR Text Key241394495
Report Number1818910-2021-05551
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeHR
PMA/PMN NumberP070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 02/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1365-36-310
Device Catalogue Number136536310
Device LOT Number3190861
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/15/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/19/2021 Patient Sequence Number: 1
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