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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Toxicity (2333)

Event Date 01/19/2014

Event Type  Injury  

Event Description

Pain patient submitted medwatch (b)(4) stating: i have 2 birmingham total hip replacements implanted 2008.I have metallosis, pseudotumors, 75% of my abductor tendon was dissolved by metal ions.I have had 1 hip revised and the other scheduled for (b)(6).I have suffered with severe chronic fatigue since 2009.

Manufacturer Narrative

• Brand Name: BHR ACETABULAR CUP
• 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: 4873831
• MDR Text Key: 5863733
• Report Number: 3005477969-2015-00186
• 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,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/13/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention