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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 Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. (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, ¿revisions of metal-on-metal hip resurfacing: lessons learned and improved outcome¿ by koen a. Sesmet, md, published by orthopedic clinics north america (2011), no. 42, pp. 259-269, was reviewed. The aim of this retrospective, consecutive case series of a single surgeon was to assess the outcome following revision of mom hemiarthroplasties. In addition, the authors assessed whether the lessons learned from the initial previously reported experience improved outcome, and whether screening with the use of metal ions had an effect on post-revision outcome. This complaint captures the revised depuy mom components. The products used at revision are unknown. Implanted products: 10 asr hemiarthroplasties (cup and head) and 2 asr xl thas (cup, head, augment). The remainder of the 113 hips studied were from competitor products. Results: the results of this study were not separated by product and/or manufacturer. This complaint will capture all reported reasons for revision surgery and intraoperative findings. 57 cup malpositioning. 15 cup loosening. 11 head misposition. 21 head loosening. 57 osteolysis (acetabular and femoral). 6 periprosthetic femur fractures. 6 infections. 40 elevated blood heavy metal. Mean co 22. 42 ppb and mean cr 22. 39 ppb. Intraoperative findings: osteolysis, unspecified impingement, oversized components (unspecified components and locations), metallosis, metal debris, hypersensitivity (pseudotumor), and soft tissue fluid collections, and ground swelling. There were six instances of femoral component loosening attributed to pseudotumor formation. The authors found significant wear on the bearing surfaces intraoperatively. Only 4 patients requiring surgery reported no pain. This complaint captures all adverse events and intraoperative findings listed within the article. The authors do not specify which product or manufacturer is associated with each event. Included within this complaint: 1 asr hemiarthroplasty (head and cup) and 1 ars-xl (head, cup, augment). The implants used in the revision surgery were competitor products and are therefore not captured within this complaint. The authors provide radiographic evidence and patient identifiers for one patient having an asr hemiarthroplasty revised. This information is captured on the attached guidance document and should be linked to parent (b)(4). " this pc contains one additional pc to capture a single case study within the article labeled 49 yo female. Please link the additional pc to the parent (b)(4). This complaint is for the asr hemiarthroplasty.
 
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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 46582
6107428552
MDR Report Key9250196
MDR Text Key179437262
Report Number1818910-2019-112836
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeBE
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 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
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: 10/29/2019 Patient Sequence Number: 1
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