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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 UNKNOWN HIP IMPLANT

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DEPUY INT'L LTD. 8010379 UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK HIP
Device Problems Nonstandard Device (1420); Insufficient Information (3190)
Patient Problems Infarction, Cerebral (1771); Transient Ischemic Attack (2109); Depression (2361); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 05/17/2014
Event Type  Injury  
Manufacturer Narrative
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: unavailable.
 
Event Description
Litigation record received. Litigation alleges increased metal values and stroke.
 
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Brand NameUNKNOWN HIP IMPLANT
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key7086277
MDR Text Key194238187
Report Number1818910-2017-50811
Device Sequence Number0
Product Code KWA
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 11/06/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 12/06/2017 Patient Sequence Number: 1
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