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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Pocket Erosion (2013); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Injury (2348); Test Result (2695); No Code Available (3191)
Event Date 07/17/2017
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. Device was used for treatment, not diagnosis. This report is for an unknown device/unknown lot. Part and lot number are unknown; udi number is unknown. (b)(4).
 
Event Description
Asr litigation records received. Litigation alleges pain, swelling, elevated blood cobalt and chromium, injury, discomfort, poor balance, difficulty walking, clicking, bone erosion, femoral and acetabular loosening, impingement, metallosis and emotional distress. Doi: (b)(6) 2009 - dor: (b)(6) 2017 (right hip).
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581
6107428552
MDR Report Key8344926
MDR Text Key136322251
Report Number1818910-2019-84763
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received02/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/15/2019 Patient Sequence Number: 1
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