MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETLR CUP HAP 52MM W/ IMPTR

Model Number 74120152

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

It has been established that, contrary to our initial report, revision surgery did not occur.Please disregard this submission.

Event Description

Revision bhmh bilateral left has been reported.The revision of the right hip of the same patient was reported earlier today under report no.3005477969-2014-00564.

• Brand Name: BHR
• Type of Device: ACETLR CUP HAP 52MM W/ IMPTR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; oberneuhofstrasse 10d; baar; SZ 6340 ; 4419264823
• MDR Report Key: 4257544
• MDR Text Key: 12888005
• Report Number: 3005477969-2014-00565
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120152
• Device Catalogue Number: 01/31/2011
• Device Lot Number: 59761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2015
• Date Device Manufactured: 02/07/2006
• 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
• Treatment: SYN POR STEM SZ 12: (B)(4), LOT 05JM05756A; MODULAR HEAD 46 MM -8MM: (B)(4), LOT 53107
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR