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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 Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 09/03/2014
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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.(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
Literature article entitled, ¿the inflammatory phenotype in failed metal-on-metal hip arthroplasty correlates with blood metal concentrations¿ by erja-leena paukkeri, et al, published by plos one (2016), vol.11, no.5, 13 pages, doi:10.1371/journal.Pone.015512, was reviewed.In the present study, the authors aimed to have another approach to investigate and understand the cell types and mechanisms involved in armd by utilizing flow cytometry to further characterize the tissue reaction in failed mom implants using tissue obtained from asr revisions as an example.Implanted products: there were 4 asr resurfacing systems and 12 asr-xl systems studied in this article.Results: each of the 16 implants studied was revised.The revisions were divided into 1) revised due to pseudotumor, 2) revised due to elevated blood metal ions, and 3) revised due to unspecified ¿symptoms¿ that included pain, joint instability, and/or decreased joint range of motion.Every patient in the study had intraoperative confirmation of pseudotumor, soft tissue necrosis, and armd.The authors confirm that each patient had histologically confirmed elevated inflammatory markers, but there were no cases of infection identified.This complaint captures 16 total patients labeled cases 1-case 16 on the guidance sheet.Each case identifies the specific implant and associated events.Please link all related pcs to this parent (b)(4).(b)(6) yo female patient with asr-xl implant.Revised 81 months after index tha due to elevated blood metal ions- co.12.2 ppb and cr.20.0 ppb, and "symptoms" including pain, joint instability, decreased joint range of motion, and/or joint noise.Pseudotumor, armd, and soft tissue necrosis confirmed intraoperatively.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: corrected: mfr site.Product complaint # (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in (b)(6) 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-001226.Ongoing post market surveillance is conducted per our procedures for this product.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN HIP ACETABULAR CUP
Type of Device
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key9276287
MDR Text Key184828360
Report Number1818910-2019-111635
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Date Manufacturer Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
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