MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Swelling (2091); Tissue Damage (2104)

Event Date 04/27/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to alval and pseudotumour.Bilateral implantation and revision procedures.This is for right side.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, 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: [211561 summary.Pdf].

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7935569
• MDR Text Key: 122786509
• Report Number: 3005975929-2018-00365
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552297
• UDI-Public: 03596010552297
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 74122154
• Device Lot Number: 09DW23015
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356107/ANTHOLOGY HO POROUS SZ 7/10HM11532; 74222148/BHR MODULAR HEAD 48MM/09DW23058; 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14/10BW2577
• Patient Outcome(s): Hospitalization; Required Intervention