MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS BHR ACETABULAR CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Udi-di: unconfirmed.Smith & nephew orthopaedics ltd.Is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew orthopaedics ltd has not been able to investigate or verify prior to the required reporting date.

Event Description

It was reported that revision surgery of the acetabular cup was performed.

Manufacturer Narrative

Update of attached investigation summary.Evaluation codes previously reported remain unchanged.

• Brand Name: BHR ACETABULAR CUP 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau, FL 5001 ; SZ 5001
• MDR Report Key: 5052664
• MDR Text Key: 24892115
• Report Number: 3005477969-2015-00247
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2012
• Device Catalogue Number: 74120152
• Device Lot Number: 71591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2007
• 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: 78 YR