MAUDE Adverse Event Report: SMITH & NEPHEW ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122150

Device Problem Noise, Audible (3273)

Patient Problems Toxicity (2333); Reaction (2414)

Event Date 04/22/2015

Event Type  Injury  

Event Description

Revision surgery was performed due to a squeaking noise reported in the 6 months prior.Soft tissue reaction, metallosis and possible edge wear reported.

Manufacturer Narrative

Manufacturer Narrative

• Brand Name: ACETABULAR CUP HAP SIZE 44/50
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD.; aurora, spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg, FL 33716 ; 4419264823
• MDR Report Key: 4729452
• MDR Text Key: 5740985
• Report Number: 3005477969-2015-00130
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• 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 Model Number: 74122150
• Device Catalogue Number: 74122150
• Device Lot Number: 09DW22913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR