MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Tingling (2171); Injury (2348); Numbness (2415)

Event Date 12/04/2015

Event Type  Injury  

Event Description

It was reported that a revision surgery on left hip was performed due to pain, difference in leg length, numbness, tingling, swelling, weakness, and heightened metal levels.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, difference in leg length, numbness, tingling, swelling, weakness, and heightened metal levels.During the revision the bhr head was removed.The bhr cup remained implanted.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 devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.According to the provided implantation report, the hip resurfacing was performed due to osteoarthritis secondary to perthes disease (idiopathic avascular osteonecrosis) and developmental dysplasia.Inadequate bone stock due to osteonecrosis or avascular necrosis with involvement of more than 50% involvement of the femoral head is a contraindication for bhr resurfacing's (surgical technique, us 2006).However, during the implantation, the femoral head was deemed suitable for a resurfacing, but to achieve appropriate anatomical restoration, a slight area of the femoral neck bone remained uncovered by the femoral component.According to the provided revision report, there was radiographic evidence of subsidence of the femoral component and the patient had pain.During the revision this component was found to be loose, some fluid within the capsule and synovitis, osteolysis around the anterior neck and the acetabular rim.As the results from the mentioned pathologic and microbiologic analysis was not provided the nature of the reported loosening, synovitis and osteolysis cannot be assessed.Without x-rays available, the situation and fixation of the femoral component cannot be assessed and further investigation on the underlying reasons for the reported findings cannot be performed.It was noted that use of a competitor¿s (stryker) dual mobility liner was implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, ¿do not mix components from other manufacturers¿.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: RESURFACING FEMORAL HEAD 46MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 7613474
• MDR Text Key: 111458989
• Report Number: 3005975929-2018-00215
• 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: other
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 74121146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120154/081426; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR