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

Catalog Number 74120158

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Pleural Effusion (2010); No Code Available (3191)

Event Date 04/24/2012

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Patient experienced pain, effusion, adverse reaction to metal debris and acetabular component migration.Mri reportedly showed anteverted acetabular cup.Femoral head remained implanted.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.Patient experienced pain, effusion, armd and acetabular component migration.As of today, device return and additional information has been requested for this complaint but has not become available.The device batch/lot details have not been received therefor no thorough manufacturing record review and assessment of the reported event can be performed.The available medical documents were reviewed.According to the provided revision report, the patient had pain and an effusion, which were related to adverse reaction to wear debris.This was based on loosening and migration of the acetabular component into a more anteverted position.There were no signs of infection described.Based on the provided information, the loosened and migrated cup caused the adverse reaction to metal debris.The cause for the loosening remains unclear.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

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: [186867 summary.Pdf].

• Brand Name: BHR ACETABULAR CUP 58MM
• 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: 7402317
• MDR Text Key: 104539615
• Report Number: 3005975929-2018-00117
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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: 74120158
• Device Lot Number: 080258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121146, LOT # 74552; FEMORAL HEAD, # 74121146, LOT # UNKNOWN; FEMORAL HEAD, # 74121146, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR