MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121146

Device Problems Bent (1059); Break (1069)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/08/2015

Event Type  Injury  

Event Description

Patient with a initial bhr implantation 8 years ago, is an active tennis player who approximately 4 weeks ago started to have discomfort in his left hip.Then while playing tennis he felt a "pop" in the left hip, followed by increasing pain.X-rays in the surgeons office showed a bhr with a stem that is bent/broken under the bhr head.The bhr was revised to a standard total hip.The bhr implant has been sent to the hospital pathology department and will be retained by the hospital.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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
• MDR Report Key: 4924653
• MDR Text Key: 19810603
• Report Number: 3005477969-2015-00192
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2012
• Device Model Number: 74121146
• Device Catalogue Number: 74121146
• Device Lot Number: 076774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2007
• 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: 63 YR
• Patient Weight: 81