MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC

Catalog Number 74122158

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 01/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Right hip revision surgery was performed due to pain and elevated metal ion levels and multiple other systemic symptoms, including squeaking and grinding.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain and elevated metal ion levels and multiple other systemic symptoms including haemoglobin of 18.During the revision the bhr head and bhr cup were removed.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.The reported elevated blood metal ion concentration present about eight months pre revision is comprehensible.Since no additional lab reports were received, the history of the patients' blood metal concentration and its potential change in time cannot be assessed.Since neither x-rays nor explants were available for investigation, no determination of the position of the prosthesis and the linear wear of the metal bearing is possible.In further consequence no assessment on a potential correlation of blood metal ion concentration and prosthesis position/performance can be made.The left hip joint was treated with a bhr resurfacing prosthesis as well.Whether the elevated blood metal ion concentration relates to the performance of one specific hip side remains elusive.Based on the surgical report of implantation the patient's retroversion hip situation requested corresponding surgical measures.Additionally, at revision surgery, a fracture in the right femur was determined.In which way this findings were related to the reported hip problems of the patient cannot be assessed conclusively.No assessment on the reported systemic problems is possible based on the available information.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.

• Brand Name: BHR ACETABULAR CUP 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 5390707
• MDR Text Key: 36885984
• Report Number: 3005477969-2016-00027
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 74122158
• Device Lot Number: 08JW18795
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74123152, LOT # 08DW16860
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR