MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TAPER SLEEVE ADAPTER 12/14 +8; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800108

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Pyrosis/Heartburn (1883); 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

(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, ¿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.40-year-old 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.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TAPER SLEEVE ADAPTER 12/14 +8
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9348670
• MDR Text Key: 184985300
• Report Number: 1818910-2019-116439
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Remedial Action: Recall
• 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 Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999800108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention