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

Catalog Number 74121146

Device Problems Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 04/04/2019

Event Type  Injury  

Event Description

It was reported a left hip revision due to persistent pain, metallosis and failed left hip arthroplasty.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.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.A review of the complaint history for the bhr cup and bhr head, was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the bhr cup and bhr head.However, as bhr systems of this size are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.The available medical documents were reviewed.Based on the revision operative reports, it was stated that there was no metallosis seen.The patient¿s elevated cobalt level prior to revision may be consistent with findings associated with metal debris.Of note, the patient is diagnosed with hemochromatosis homozygous as well as multiple myeloma, for which she received infusion therapy of zometa, in which the warnings and precautions listed provided with zometa include atypical subtrochanteric and diaphyseal femoral fractures which may occur after minimal or no trauma.The patient¿s multiple zometa infusions and underlying disease processes cannot be ruled out as contributing factors to her persistent pain, elevated cobalt level, periprosthetic fracture and subsequent revisions.Based on the provided information the source of the reported findings cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative healing/pain cannot be determined.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: 9586416
• MDR Text Key: 174876203
• Report Number: 3005975929-2020-00013
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74121146
• Device Lot Number: 090141
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120152 ACETLR CUP HAP 52MM W/IM 090685
• Patient Outcome(s): Hospitalization; Required Intervention