MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Encephalopathy (1833); Metal Related Pathology (4530)

Event Date 01/12/2017

Event Type  Injury  

Event Description

It was reported that, six years after a revision surgery in which a bhr system had been replaced with a metal-on-metal system on both hips, the patient became severly disabled and was diagnosed with metallosis and arthroplastic cobalt encephalopathy.It is unknown if/how the patient has been treated.

Manufacturer Narrative

It was reported that the patient was diagnosed with metallosis.It is unknown if a revision surgery has been performed.The implanted devices, were all used in treatment.Additional information has been requested for this complaint but has not become available.No part/lot numbers were provided; hence documentation review could not be completed.If more information is received, this investigation will be reopened.The complaint information was reviewed.However, no medical documents, lab reports or x-rays related to the reported event has been provided for inclusion in this investigation.Therefore, a thorough medical assessment is not able to be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.Without 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.

Manufacturer Narrative

It was reported that the patient underwent a right hip revision.The implanted devices, all of which were used in treatment & additional information has been requested for this complaint but has not become available.No part/lot numbers were provided hence a documentation review could not be completed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The medical documents were reviewed.Based on the clinical information provided, of the elevated metal ion levels and the effusions may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.Post removal levels of cobalt and chromium were not provided.Without 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.

Manufacturer Narrative

It was reported that the patient underwent a revision operation.As of today, the implanted devices, all of which were used in treatment & additional information has been requested for this complaint but has not become available.Since the device part details have not been received for investigation no thorough manufacturing record review can be performed.A risk management review was performed.No additional risks were identified as a result of the reported event.The medical documents were reviewed.Based on the clinical information provided, of the elevated metal ion levels and the effusions may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The symptoms and details around his reported encephalopathy were not provided.Post removal levels of cobalt and chromium were not provided.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10446127
• MDR Text Key: 204176140
• Report Number: 3005975929-2020-00320
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability