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

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.".

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.Corrected: mfr site and report source.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-001226.Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 13
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9348663
• MDR Text Key: 185093833
• Report Number: 1818910-2019-116442
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168799
• UDI-Public: 10603295168799
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3L92513
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention