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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Loss of Osseointegration (2408); Naturally Worn (2988); Unintended Movement (3026)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Pocket Erosion (2013); Scarring (2061); Joint Disorder (2373); Osteolysis (2377); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
Event Date 12/19/2017
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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 medical records received. After review of medical record, the patient was revised to address failed right total hip replacement involving articular surface wear, adverse local tissue response, and periprosthetic osteolysis, aseptic loosening of the acetabular component, acetabular erosion and pseudocyst of the thigh. Revision notes reported large osteolytic cyst. The posterior aspect of the thigh appeared to be filled with murky fluid which was stained black. Scar formation was noted. Patient's hip was quite stiff. There was notching of the anterior neck of the femoral component by approximately 2-3 mm, suggesting it was impinging on the anterior aspect of his metal on metal component. There was small osteolytic lesion in zone 7. Acetabular component was grossly loose and was clearly mobile. Clinical visits reported pain, elevated metal ions, and cystic mass of 10. 5 cm. Doi: (b)(6) 2009 - dor: (b)(6) 2017, (right hip).
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8804791
MDR Text Key151508033
Report Number1818910-2019-98729
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
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 Received07/24/2019
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 Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 07/18/2019 Patient Sequence Number: 1
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