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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 VISION 2000 SIZE 13.5 SM L MISCELLANEOUS HIP STEM : HIP FEMORAL STEM

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DEPUY INTERNATIONAL LTD - 8010379 VISION 2000 SIZE 13.5 SM L MISCELLANEOUS HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 960128000
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 01/01/2019
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

Surgeon is reporting a fracture of a ceramic hip inlay left side. Doi: 2006, dor: not planned yet as a continuing care inlay needs to be manufactured first.

 
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Brand NameVISION 2000 SIZE 13.5 SM L
Type of DeviceMISCELLANEOUS HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9793262
MDR Text Key182180310
Report Number1818910-2020-06940
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup
Report Date 08/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number960128000
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/05/2020 Patient Sequence Number: 1
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