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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 Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Anxiety (2328); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive. Further investigation of this individual incident will not be undertaken. The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- (b)(4). Ongoing post market surveillance is conducted per our procedures for this product. 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. No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically.
 
Event Description
English translation of (b)(6) legal document received. This is a request for initiation of mediation procedure alleging progressively severe pain, limping gait, instability, functional limitations of the lower limb, inflammation, presence of accumulation of chromium and cobalt metal ions in the patient's blood leading to metallosis and presence of a voluminous cyst in the right coxofemoral region. The document further indicates that the patient developed moderate to severe persistent depressive disorder related to stress directly connected to the consequences of the trauma suffered by the patient, partly increased by her knowledge of the damage caused by having the depuy asr prosthetic system. This resulted to severe anxiety and significant obsessive-phobic manifestations, depressed mood, excessive irritability and reactivity. Doi: somewhere between (b)(6) 2009 - dor: no revision reported (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 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 Key9410074
MDR Text Key169054291
Report Number1818910-2019-120140
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
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 Received08/10/2020
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 Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 12/04/2019 Patient Sequence Number: 1
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