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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); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Test Result (2695); No Code Available (3191)
Event Date 07/11/2019
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. (b)(4).
 
Event Description
The literature article entitled, "host-specific factors affect the pathogenesis of adverse reaction to metal debris" written by lari lehtovirta, aleski reito, olli lainiala, jyrki parkkinen, harry hothi, johann henckel, alister hart, and antti eskelinen published by bmc musculoskeletal disorders published 2019 was reviewed. The article's purpose to assess whether the development of armd (adverse reaction to metal debris) is actually affected by host-specific intrinsic factors. Data was compiled from 29 patients with bilateral revision of depuy asr mom hips (58 hips). It is noted that 24 patients had depuy asr xl thas but the femoral stem is not identified. It is unknown if these patients had bilateral thas or if a combination of hra and tha was utilized for these patients. The article does not provide adequate information to determine accurate quantities. All revisions were for armd with some patients receiving revision to one side at the first revision and the contralateral hip revised at the 2nd revision verse bilateral revisions at the same revision. The intraoperative findings and subjective reports are captured as adverse events in this complaint. Depuy products: asr head, asr cup, asr xl head, asr xl sleeve (augment), asr xl cup. Adverse events: revision for armd attributed to mom bearing wear. Reports of pain. Aseptic cup loosening. Elevated metal ion levels. Pseudotumor. Sense of instability. Sounds from hip (clacking, squeaking). Soft tissue necrosis via histopathological analysis.
 
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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 8DT
UK LS11 8DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581
6107428552
MDR Report Key10308497
MDR Text Key199988110
Report Number1818910-2020-16518
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
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: 07/22/2020 Patient Sequence Number: 1
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