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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +5 HIP FEMORAL SLEEVE

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DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +5 HIP FEMORAL SLEEVE Back to Search Results
Catalog Number 999800315
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Event Date 04/20/2009
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation alleges that the patient suffered the following on account of his asr left hip implant: pain; discomfort; stiffness; soreness;clicking; elevated levels of cobalt and chromium. In addition, the patient has been negatively affected in his ability to ambulate causing him to walk with a limp. Litigation further alleges that the patient has been explanted. Update apr 11, 2018: asr litigation records received. In addition to what was previously reported, patient alleges anxiety, inability to perform normal activities, suffering and emotional distress. Added date of revision, account name and associated contact. Added stem and cup due to alleged elevated metal ion levels. Doi: (b)(6) 2009 : dor: (b)(6) 2017 (left hip).
 
Manufacturer Narrative
(b)(4). Investigation summary : 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.  .
 
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Brand NameADAPTER SLEEVES 12/14 +5
Type of DeviceHIP 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 46582
6107428552
MDR Report Key7490878
MDR Text Key107485953
Report Number1818910-2018-59026
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
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 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2014
Device Catalogue Number999800315
Device Lot Number2823781
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 Received06/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/21/2009
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: 05/07/2018 Patient Sequence Number: 1
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