MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222148

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

Patient Problems Ankylosis (4527); Metal Related Pathology (4530)

Event Date 11/11/2015

Event Type  Injury  

Event Description

It was reported that a patient had elevated ion levels diagnosed on (b)(6) 2015 finding cobalt 7.67 ppm / chrome 3.38 ppm.No revision surgery has been scheduled nor performed to the patient.The patient status is unknown.

Manufacturer Narrative

H3, h6: it was reported that a clinical study patient had elevated ion levels.As of today, additional information has been requested for this complaint but have not become available.As no lot numbers were provided, a complete complaint history review cannot be performed for the devices involved.A complaint history review was performed using the part numbers provided for the bhr cup, modular head, modular neck and stem in search of similar complaints throughout the lifetimes of the products.Similar complaints have been identified.This will continue to be monitored.As no device lot numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.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.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without further information we cannot 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.

• Brand Name: BHR MODULAR HEAD 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11408892
• MDR Text Key: 234613722
• Report Number: 3005975929-2021-00116
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552471
• UDI-Public: 3596010552471
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74222148
• Device Lot Number: UNKN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention