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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR TAP SLV ADAP 12/14 -1 ASR HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY INTERNATIONAL LTD - 8010379 ASR TAP SLV ADAP 12/14 -1 ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999890353
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 11/28/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr plaintiff preliminary disclosure received. Ppd has no allegation provided. Doi: (b)(6) 2008; dor: (b)(6) 2018: right hip.
 
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Brand NameASR TAP SLV ADAP 12/14 -1
Type of DeviceASR HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10302113
MDR Text Key199683262
Report Number1818910-2020-16383
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2013
Device Catalogue Number999890353
Device Lot Number2542927
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 Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2008
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: 07/21/2020 Patient Sequence Number: 1
Treatment
ASR ACETABULAR CUPS 48; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 43; UNKNOWN HIP FEMORAL STEM
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