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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 49 HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 49 HIP FEMORAL HEAD Back to Search Results
Catalog Number 999890149
Device Problem Noise, Audible (3273)
Patient Problems Dyspnea (1816); Fatigue (1849); Foreign Body Reaction (1868); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Weakness (2145); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 09/08/2019
Event Type  Injury  
Manufacturer Narrative
(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
The patient reports that the procedure and the rehabilitation was successful. (b)(6) 2007: lumbar pain appeared. In 2008: hip pain appeared with abnormal noises which resonated throughout the leg. The analyses was revealed at least 3 kinds of infectious germs. On (b)(6) 2008 :a control radio was carried out, observing a the bascule of the pelvis. In 2009: new symptoms: the patient was short, of breath at the slightest effort (difficulty to walk, to move due to fatigue and weakness of the operated leg). The patient was treated with analgesics. On (b)(6) 2017: the control radio before the total hip revision. The report presents the hypothesis of a prosthetic detachment with formation of foreign body granuloma. On (b)(6) 2017: patient has severe pain on a metal-metal hip prosthesis with a large head and bone destruction on the femur.
 
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Brand NameDEPUY ASR XL FEM IMP SIZE 49
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds IN LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds IN LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9559537
MDR Text Key188990340
Report Number1818910-2020-00932
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number999890149
Device Lot Number2285621
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2006
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: 01/07/2020 Patient Sequence Number: 1
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