MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120144

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

Patient Problems Cardiomyopathy (1764); Death (1802); Toxicity (2333)

Event Date 12/01/2019

Event Type  Death  

Event Description

It was reported that a patient had suspected cardiomyopathy from hip resurfacing.An orthopaedist measure cobalt level at 5244 (no unit of measure supplied) on (b)(6) 2019.A surgical intervention was planned but the patient was too ill from the cardiomyopathy.The patient died on (b)(6) 2019.

Manufacturer Narrative

It was reported that a patient had suspected cardiomyopathy from hip resurfacing.Surgical intervention was planned but the patient was too ill from the cardiomyopathy and later died.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.These circumstances were escalated to management in accordance with preliminary risk assessment/ health hazard evaluation procedure.Quality management have been notified accordingly.No part/lot numbers were provided; hence documentation review could not be completed.If more information is received, this investigation will be reopened.As of today, no medical records have been received.It was reported that a patient with cardiomyopathy had a bhr implanted.In (b)(6) 2019, a revision was planned due to elevated cobalt levels.However, the orthopaedist determined the patient was too ill from the cardiomyopathy, for surgical intervention.It was further reported that the patient died on (b)(6) 2019.Without any supporting medical evidence, the reported event cannot be assessed and a thorough medical assessment cannot be performed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Event Description

It was reported that the patient presented to the hospital with decompensated heart failure, new-onset paroxysmal atrial tachycardia and increasing left hip pain on 2019.Imaging of his left hip demonstrated radiographic evidence of bony changes, suggestive of an adverse reaction to metal debris (armd), along with a non-traumatic left peri-prosthetic neck-of-femur fracture and subluxation.The patient had concurrent decompensated cardiomyopathy requiring dopamine and furosemide infusions in the past.Despite successful chelating therapy and heart failure treatment, the patient passed away on (b)(6) 2019 secondary to cobalt toxicity induced cardiomyopathy (ctcm).The patient had a primary bhr surgery in the left hip on 2012.

• Brand Name: ACETABLR CUP HAP 44MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; 0447940038
• MDR Report Key: 9490191
• MDR Text Key: 171888513
• Report Number: 3005975929-2019-00439
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74120144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN BIRMINGHAM HIP RESURFACING HEAD
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Sex: Male