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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 Corroded (1131); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Osteolysis (2377); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 01/01/2016
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, "histopathological characterization of corrosion product associated adverse local tissue reaction in hip implants: a study of 285 cases" written by benjamin f. Ricciardi, allina a. Nocon, seth a. Jerabek, gabrielle wilner, elianna kaplowitz, steven r. Goldring, p. Edward purdue and giorgio perino published by bmc clinical pathology ricciardi et al. Bmc clinical pathology (2016) 16:3 doi 10. 1186/s12907-016-0025-9 was reviewed. The article's purpose: "the purpose of this study was to describe the histological patterns observed in the periprosthetic tissue of failed tha in three different implant classes due to altr and their association with clinical features of implant failure. " depuy products utilized: asr resurfacing, asr xl, pinnacle ultramet, mom bearing srom - all retrieved as failures due to altr - all bearing surfaces mom. Adverse events: soft tissue necrosis, metallic and black particles (debris contributed to wear and corrosion), device corrosion, osteolysis (contributed to foreign body debris), hypersensitivity (noted by increased macrophages, lymphocytes, eosinophils), elevated blood ion levels ranging 0-169 co and 0-64 cr. As the article does not specify which product platforms are associated with specific adverse events, platforms are grouped and captured as 1 impacted product for each product type. The article does not provided adequate information to determine accurate quantities.
 
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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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9342307
MDR Text Key185011227
Report Number1818910-2019-115030
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
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 Received12/23/2019
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: 11/19/2019 Patient Sequence Number: 1
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