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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE

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DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Synovitis (2094); Injury (2348); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Physical Asymmetry (4573)
Event Date 12/22/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Initial reporter occupation: lawyer. (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
Asr hip mom litigation record received. The litigation alleges severe pain, elevated ions level, loss of wages past and future, trouble sleeping and walking, emotional distress, and other illness and injuries. Asr hip implant was revised due to elevated levels of cobalt and chromium ions, metallosis, adverse reaction to metal debris. Revision operative note mentioned of synovitis and inflammatory tissue. Doi: (b)(6) 2009, dor: (b)(6) 2018, (left hip).
 
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Brand NameADAPTER SLEEVES 12/14 +2
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)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9897463
MDR Text Key186279929
Report Number1818910-2020-09558
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
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2014
Device Catalogue Number999800312
Device Lot Number2927600
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 Received07/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2009
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: 03/30/2020 Patient Sequence Number: 1
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