MAUDE Adverse Event Report: SMITH & NEPHEW BHR; DYSPLASIA CUP

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 11/27/2007

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to implant movement, broken screw and pain.The femoral head remained implanted.

Manufacturer Narrative

(b)(4).

• Brand Name: BHR
• Type of Device: DYSPLASIA CUP
• Manufacturer (Section D): SMITH & NEPHEW; 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: terry mcmahon ; 970 lake carillon drive; st. petersburg, FL 33716 ; 4419264823
• MDR Report Key: 4747275
• MDR Text Key: 5773365
• Report Number: 3005477969-2015-00138
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• 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: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention