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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Test Result (2695); Not Applicable (3189); 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 attached guidance sheet. Each case identifies the specific implant and associated events. Please link all related pcs to this parent (b)(4). " (b)(6) yo male with asr-xl implant. Revised 39 months after index hra due to due to elevated blood metal ions- co. 10. 5 ppb and cr. 3. 3 ppb, pseudotumor, and "symptoms" including pain, joint instability, decreased joint range of motion, and/or joint noise. Pseudotumor, armd, and soft tissue necrosis confirmed intraoperatively.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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 46581-0988
6107428552
MDR Report Key9274566
MDR Text Key184838114
Report Number1818910-2019-112542
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeNL
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 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
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received10/14/2019
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: 11/04/2019 Patient Sequence Number: 1
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