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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Sepsis (2067); No Code Available (3191)
Event Date 08/27/2009
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. (b)(4).
 
Event Description
Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement a consequence of excess wear by d. J. Langton, s. S. Jameson, t. J. Joyce, n. J. Hallab, s. Natu, and a. V. F. Nargol published by the journal of bone & joint surgery on 27 august 2009. The article's purpose: "we sought to establish the rate of failure secondary to adverse reactions to metal debris (armd) in our patients, to identify relationships between this mode of failure and the wear rate of the prosthetic joint, and to provide a potential explanation for the increased incidence of this in women. For the purposes of this paper we therefore use the acronym ¿armd¿ as an umbrella term to describe joint failures associated with pain, a large sterile effusion of the hip and/or macroscopic necrosis/metallosis. " the study was of 505 asr devices (87 of those were thrs) and 155 bhrs from 2002 to 2009 (bhrs were from 2002 to april 2004 and asr was used there after). Table iii lists 17 cases of revision with patient identifiers captured in linked complaints listing descriptive findings of armd. Additionally, table iv included data from other asr revision cases without patient identifiers with reasons of revision as pain, effusion, pseudotumor and fracture (anatomical location not given). It is noted that chromium levels were in the range of 3. 89 to 41. 8 and cobalt 7. 82 to 99. 1 for the patients in this study. For histopathological examination of tissues from revision procedures of the 17 identifiable cases: "the various layers of the neocapsule were studied. Layer 1 consists of the surface membrane and was graded as type 1 to 4. 17 type 1 surfaces have an intact pseudosynovial membrane. Type 2 surfaces show a loss of the pseudosynovial membrane. Type 3 surfaces are associated with fibrin deposition in addition to the loss of the surface membrane, and in type 4 there is gross disruption of the surface membrane with fibrin deposition and fissuring. Layer 2 is the subsynovial layer, which usually contains the inflammatory infiltrate. Layer 3 is the vascular layer, which contains the perivascular lymphocyte cuffing. Layer 4 is the deeper layers containing muscle fat and fibrous tissue. The thickness of the histiocyte band containing particulate matter in layer 2 was measured using the graticule. The presence of perivascular lymphocytic cuffing and its average thickness in layer 3 was also recorded. " impacted products: asr & asr xl. Adverse events: surgical intervention, foreign body reaction, soft tissue necrosis, pain, hypersensitivity, blood heavy metal increased.
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds IN LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8975504
MDR Text Key161523223
Report Number1818910-2019-103483
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/09/2019 Patient Sequence Number: 1
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