MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF INTERFIT ACET TH SZ 50; ACETABULAR SHELL

Catalog Number 71336050

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision hip surgery was performed to replace the cup, liner and femoral head due to infection.

• Brand Name: RF INTERFIT ACET TH SZ 50
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5352420
• MDR Text Key: 35316454
• Report Number: 1020279-2016-00030
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71336050
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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