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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HIP BA BIO 28MM 12/14 + 1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 HIP BA BIO 28MM 12/14 + 1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 9111121
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Joint Dislocation (2374); Insufficient Information (4580)
Event Date 06/18/2020
Event Type  Injury  
Manufacturer Narrative

Product complaint # (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

Surgeon reported to nca (bfarm): "inlay dislocation with ceramic head fracture of hip tep left side with necessary revision surgery on (b)(6) 2020, see detailed surgery report dated (b)(6) 2020. Initial implantation of the cementless hip replacement on (b)(6) 2014 in hospital (b)(6). ".

 
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Brand NameHIP BA BIO 28MM 12/14 + 1.5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
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 Key11107867
MDR Text Key227563345
Report Number1818910-2021-28140
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
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 12/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number9111121
Device LOT Number7864609
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/19/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2014
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: 01/04/2021 Patient Sequence Number: 1
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