MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Swelling (2091); Toxicity (2333)

Event Date 06/23/2015

Event Type  Injury  

Event Description

A revision surgery of the right hip has been performed due to pseudotumour-metalosis.The revised left hip of this patient is filed under 3005477969-2015-00074.

• Brand Name: BHR ACETLR CUP HAP 56MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• 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 ; 0628320660
• MDR Report Key: 4897810
• MDR Text Key: 6537935
• Report Number: 3005477969-2015-00189
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2015
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 10CW26181 008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2010
• 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: 58 YR
• Patient Weight: 84