MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD DYSPL CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number OR74120254

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems No Known Impact Or Consequence To Patient (2692); Test Result (2695)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Event Description

Patient suing medical personnel at the orthopaedics and traumatology clinic, independent public teaching hospital fo failure to failure to exercise due care and diligence in performing diagnostic tests and improper decisions.Revision surgery planned.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Attachment: [122376 summary.Pdf].

Event Description

It was reported that revision surgery is planned for early 2019.High levels of metal ions have been confirmed in the medical fields at home and abroad.Despite the lack of clinical features of loosening the hip implant, an indication was given to remove the right hip prosthesis.The patient consulted a us surgeon, who advised that the implant needs to be replaced.However the patient's local polish hospital does not want take responsibility of the surgery.

Event Description

T was reported that a revision surgery was performed on (b)(6) 2019 due to elevated metal ions.Primary surgery was performed on (b)(6) 2006 and since 2014, the patient was diagnosed with a systemic reaction of cobalt ions emission with symptoms of neurological ¿ endocrinological complications.Despite the lack of clinical features of loosening the hip implant, an indication was given to remove the right hip prosthesis.The patient consulted a us surgeon, who advised that the implant needs to be replaced.However, the patient's local polish hospital does not want take responsibility of the surgery.

• Brand Name: DYSPL CUP HAP 54MM W/ IMPTR
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5993259
• MDR Text Key: 56173381
• Report Number: 3005975929-2016-00023
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: OR74120254
• Device Lot Number: 51245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2005
• 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
• Treatment: BHR DYSPLASIA SCREW 32 MM 74500032. LOT#3276473; BHR DYSPLASIA SCREW 48MM 74500048. LOT#05DM17636; FEMORAL HEAD, # 74121146, LOT # 50889; BHR DYSPLASIA SCREW 32 MM 74500032. LOT#3276473; BHR DYSPLASIA SCREW 48MM 74500048. LOT#05DM17636
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female