MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121150

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Synovitis (2094); Toxicity (2333); Injury (2348); No Code Available (3191)

Event Date 05/02/2013

Event Type  Injury  

Event Description

It was reported that patient underwent right hip revision surgery due to pain, failed right hip resurfacing, femoral neck fracture, synovitis, fluid around hip and metallosis.Noted as two-step revision on (b)(6) 2013 and (b)(6) 2014.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, failed right hip resurfacing, femoral neck fracture, synovitis, fluid around hip and metallosis.The bhr head removed during surgery, 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.The provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.According to the provided revision report, the patient had a femoral stress fracture at the neck and the cup remained in-vivo with good position.No possible reasons for the stress fracture were described.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.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.The available medical documents were reviewed.Patient was discharged back to work seven weeks post implantation.Patient was seen in the office with complaint of groin pain four months post implantation and was wondering if he was over-doing it.An april 2013 bone scan showed developing fracture along the medial aspect of the right femoral neck.It cannot be determined to what extent the patient¿s early return to work and the physical demands of his job had on his clinical status.All the released devices involved met manufacturing specifications at the time of production.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 50MM
• 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: 7188832
• MDR Text Key: 97288440
• Report Number: 3005975929-2018-00015
• 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,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 74121150
• Device Lot Number: 11MW35407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120156/ACETLR CUP HAP 56MM W/ IMPTR/11KW34498; ACETABULAR CUP, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR