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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING (BHR) HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING (BHR) HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number UNKNOWN
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Anemia (1706); Failure of Implant (1924); Infiltration into Tissue (1931); Injury (2348); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692); Neuralgia (4413)
Event Date 01/08/2019
Event Type  Injury  
Event Description
Eu legal case.It was reported that a bhr revision surgery was performed on the right hip of the patient, due to unknown symptoms.No further information is available at the moment, additional information will be requested.
 
Manufacturer Narrative
It was reported that right hip revision surgery was performed.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.As no device part and batch numbers were provided for investigation, a manufacturing record review, device labelling / ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical records or evidence have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot 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 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.
 
Manufacturer Narrative
It was reported that right hip revision surgery was performed.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.As no device part and batch numbers were provided for investigation, a complaint history review, 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.No medical documents or surgical reports have been provided for this investigation.The patient states that he started experiencing a deterioration in the state of health, extreme pain, difficulty walking, weight loss, lethargy, and anemia.Mobility is being assisted with walking sticks (indoors), elbow crutches (outdoors) and scooter (long distances).The pain is being managed by taking morphine, paracetamol and codeine.Although x-rays, mri scans, nuclear bone scan have been performed, nothing totally conclusive was spotted.The impact to this patient has been pain and loss of the ability to perform activities of daily living.The symptoms described by this patient, may be consistent with a reaction to metal debris.However, without medical documentation it cannot be investigated.Further, it cannot be concluded that the reported clinical findings are associated with the implant failure.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.
 
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Brand Name
BIRMINGHAM HIP RESURFACING (BHR) HEAD
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 Key10176600
MDR Text Key195902286
Report Number3005975929-2020-00210
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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