MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD DYSPL CUP HAP 46MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120246

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

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to unspecified reasons.

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.

Event Description

Revision surgery due to infection.

• Brand Name: DYSPL CUP HAP 46MM 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
• MDR Report Key: 8613118
• MDR Text Key: 145156796
• Report Number: 3005975929-2019-00207
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502650
• UDI-Public: 03596010502650
• Combination Product (y/n): N
• PMA/PMN Number: STNP040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: 74120246
• Device Lot Number: 50066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PAR 74121438, LOT 50131; PAR 74121438, LOT 50131
• Patient Age: 58 YR