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U.S. Department of Health and Human Services

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

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DEPUY INT'L LTD. 8010379 UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
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  
Event Description
Claim letter alleges cerebral stroke, elevated metal ions, walking difficulty, cerebral ischemia attributed to cr and co toxicity and depression.
 
Manufacturer Narrative
Product complaint # (b)(4). Device history lot
==
> null. Device history lot
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> null. Device history review
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> null.
 
Event Description
Litigation record received. Litigation alleges increased metal values and stroke.
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
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
pa ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key7086275
MDR Text Key192934575
Report Number1818910-2017-50841
Device Sequence Number0
Product Code KWA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/24/2019
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 ACETABULAR CUP
Was Device Available for Evaluation? 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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