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

Device Problems Biocompatibility (2886); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2017

Event Type  Injury  

Event Description

Eu legal case.It was reported that a bhr revision surgery was performed on the left 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 left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive lot numbers a complete complaint history, manufacturing record, specific product labelling and ifus review cannot be performed for the devices involved.Without the details of the devices, medical details of the reported issue, failure modes and reason for revision involved in this complaint, a specific risk management review for the devices cannot be performed.If this information becomes available at a later time, the tasks will be reopened and completed.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 left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive lot numbers a complete complaint history, manufacturing record, specific product labelling and ifus review cannot be performed for the devices involved.Without the details of the devices, medical details of the reported issue, failure modes and reason for revision involved in this complaint, a specific risk management review for the devices cannot be performed.If this information becomes available at a later time, the tasks will be reopened and completed.The available medical documents were reviewed and concluded.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.

Manufacturer Narrative

Additional information: h6 (component code).Corrected data: h6 (type of investigation).Updated results of investigation: it was reported that left hip revision surgery was performed because of pain and high metal ion levels.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, or escalation actions review could not be performed.If more information is received, this investigation will be reopened.The review of the product's current ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed for the unknown bhr head and unknown bhr cup devices.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions were able to be determined at this time due to limited information.As of the date of this investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events/clinical reactions.With the limited information provided, the patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

Manufacturer Narrative

Corrected data: b5 (narrative), h6 (health effect - impact code, health effect - clinical code, medical device problem code).

Event Description

It was reported that a bhr revision surgery was performed on the left hip on (b)(6) 2017.The revision was performed on the patient because of pain and high metal ion levels.No further information is available at the moment, additional information will be requested.

• Brand Name: BIRMINGHAM HIP RESURFACING (BHR) CUP
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; aurora house, spa park; leamington spa warwickshire CV31 -3HL ; UK CV31 3HL ; 0447940038
• MDR Report Key: 10176571
• MDR Text Key: 195902180
• Report Number: 3005975929-2020-00209
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention