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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 13 HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 13 HIP FEMORAL STEM Back to Search Results
Catalog Number 3L92513
Device Problem Corroded (1131)
Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Foreign Body Reaction (1868); Pyrosis/Heartburn (1883); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tachycardia (2095); Heart Failure (2206); Injury (2348); Test Result (2695); No Code Available (3191)
Event Date 11/23/2016
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4). (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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. Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection. Therefore no dhr (device history record) review for this individual asr component will be carried out at this point in time. The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive. The investigation to determine root cause was conducted under mdd capa (b)(4). Ongoing post market surveillance is conducted per our procedures for this product. Device history lot: null. Device history batch: null. Device history review: null. (b)(4).
 
Event Description
"literature article entitled, ¿cobalt cardiomyopathy secondary to hip arthroplasty: an increasingly prevalent problem¿ by russel tilney, et al, published by case reports in cardiology, vol. 2017, article id 5434571, 4 pages, https://doi. Org/10. 1155/2017/5434571, was reviewed. This case report discusses the possibility of metal-on-metal biotribocorrosion leading to cardiomyopathy secondary to cobalt heavy metal poisoning with partial symptomatic and echocardiographic resolution on revision of the hip arthroplasty in a (b)(6) gentleman. Depuy products: bilateral asr-xl paired with corail stems. Part numbers were provided by the authors: left hip: acetabular implant, 9998-04-754; taper sleeve adaptor, 9998-00-108; femoral implant, 9998-90-147; femoral stem, 3l92514 corail; right hip: acetabular implant, 9998-04-652; taper sleeve adaptor, 9998-00-102; femoral implant, 9998-90-146, femoral stem, 3l92513 corail. (b)(6) male with a history of alcohol and substance abuse presented four years after bilateral asr-xl/corail thr with exertional dyspnea, intermittent palpitations, and persistent tachycardia. Admission ecg revealed, severely impaired left ventricular systolic function in the absence of gross dilatation and pericardial effusion. The left ventricle also appeared hypertrophied and ejection fraction was estimated 40-45%. 1. 32l of pericardial fluid was removed during pericardiocentesis. Bacterial cultures were negative for infective microorganisms. Endomyocardial biopsy revealed damage to the myocardium and mild perivascular fibrosis. After recurring pericardial effusion, the patient was prescribed colchicine 500 mcg bd and a pericardial window was performed for management after discharge. The patient was referred back to the hospital after experiencing epigastric discomfort and tachycardia. Ecg confirmed new onset atrial fibrillation at 176 beats/min. He was anticoagulated with heparin and warfarin and urgent dc electrocardioversion was performed at 100 j under general anesthesia, restoring sinus rhythm without any complications. Ecg revealed severely impaired biventricular function with an lvef 20% and advanced diastolic dysfunction and a small localized pericardial effusion. Whole blood cobalt levels were 4174 nmol/l and the patient was diagnosed with cardiomyopathy secondary to cobalt heavy metal poisoning. Subsequent ultrasound of the right hip revealed hypoechoic fluid collection with internal scattered echogenic debris measuring 8 cm × 3 cm × 2. 5 cm located between the skin and the right greater trochanter suggestive of alval as well as a cystic mass. The left hip was unremarkable. Bilateral excision of the asr-xl/corail implants was recommended and undertaken 8months later. There were no remarkable findings on the left side, all adverse events were discovered on the right hip, intraoperatively, blackening of the gluteal muscle and greater trochanter secondary to metal debris was noted. There was corrosion of the stem taper and the hip was discovered to be dislocated. Histology demonstrated reparative and inflammatory changes with metallosis. At five months follow-up, the patient had an increased exercise tolerance and a slightly improved ejection fraction. Captured in this complaint: bilateral asr-xl/corail tha. ".
 
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Brand NameCORAIL2 STD SIZE 13
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 46581-0988
6103142063
MDR Report Key9348663
MDR Text Key185093833
Report Number1818910-2019-116442
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K042992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3L92513
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 Received11/21/2019
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

Patient Treatment Data
Date Received: 11/20/2019 Patient Sequence Number: 1
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