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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 UNKNOWN HIP ACETABULAR LINERS

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DEPUY INT'L LTD. 8010379 UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problems Nonstandard Device (1420); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); No Code Available (3191)
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
An article ¿cumulative revision rate is higher in metal on metal tha than in metal on polyethylene tha: analysis of survival in a community registry¿ by der-chen t. Huang reports on whether higher-cost mom tha implants were superior to moxp tha implants in terms of implant survival and whether survival differed between the depuy asr mom implant and other mom tha implants. It also analyses if revision for dislocation was more common in moxp or mom thas. Total 2404 patients (mom thas-1118 and moxp thas-1286); who underwent hip and knee arthroplasties from 1999 to 2001 were included in the study. Of the 1118 mom thas (mean age
=
62 years, 535 male and 583 females), 423 used asr (depuy) implants, 692 used pinnacle (depuy) implants, and there were three other mom devices. 73 out of 1118 cases underwent to revision surgery due to dislocation, periprosthetic fracture, failure of bone ingrowth, aseptic loosening, infection, pain, metal hypersensitivity, pseudotumors, metallosis and other (unknown) reasons. Location of fracture is not specified. Incidence of pseudotumor related to metallic debris was also documented by the operative surgeons. Asr implant was found to be associated with above reported adverse events.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st anthony's rd
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8876598
MDR Text Key153794187
Report Number1818910-2019-100607
Device Sequence Number0
Product Code KWY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/01/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
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 Received08/23/2019
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: 08/08/2019 Patient Sequence Number: 1
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