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

Model Number 74120156

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330); Chemical Exposure (2570); Test Result (2695)

Event Date 01/27/2015

Event Type  Injury  

Event Description

Pain patient submitted medwatch (b)(4).It stated: discomfort and pain around area where resurfacing of left hip was performed.While device was intact via x-ray, bloodwork showed cobalt and chromium levels greatly increasing over time, and mri confirmed tissues surrounding device were affected in a negative way contributing to pain and instability of hip.Consequently, a revision surgery was performed substituting the resurfacing device with a total hip replacement in 2015.The original resurfacing was performed in 2008.

• Brand Name: BHR ACETABULAR CUP HAP
• 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: 4839778
• MDR Text Key: 16887849
• Report Number: 3005477969-2015-00168
• 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: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/30/2012
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 081486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• Date Device Manufactured: 11/29/2007
• 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