MAUDE Adverse Event Report: SMITH & NEPHEW BHR

Model Number 74120154

Device Problems Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Packaging Problem (3007)

Patient Problem Toxicity (2333)

Event Date 11/30/2007

Event Type  Injury  

Event Description

I had a smith & nephew bhr in (b)(6) of 2007 and again in (b)(6) of 2009.I have had many issues, including gastric problem that i had no idea were related to metal poisoning.It is only in the last two months i have discovered that i do indeed have metal poisoning and i now have an appointment to have the hips eval for removal and replacement.The problem is, i also just found out that the actual product number i received in 2007 was one of the recalled products that smith and nephew voluntarily recalled due to improper packaging where the wrong sizes were indicated, so i have the wrong size in one hip and it has caused me nothing but issues.I told the doctors here about the problems and i was told the recall was only for hips implanted in the uk and not the us, but clearly that information was wrong, and now i am being told i have exceeded the stature of limitations because your office (fda) took on a blanket notice where once you have notified the clock began ticking on the statue of limitation and thus anyone involved needed to receive legal rep during that time or the window would expire.This is unfair of the fda.How is a person to know the lot number of their hip device? it isn't something normally known.This has ruined my life because of the gastric issues and potential issues with the revisions.For four years, i have had so many problems and i have been told numerous diagnoses, but no one thought to say it might be my hip until i saw a commercial on television that made me curious.It is truly a travesty of justice.

• Brand Name: BHR
• Type of Device: BHR
• Manufacturer (Section D): SMITH & NEPHEW
• MDR Report Key: 4397897
• MDR Text Key: 15326498
• Report Number: MW5040039
• Device Sequence Number: 1
• Product Code: NXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/03/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 74120154
• Device Lot Number: 70047
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 40 YR
• Patient Weight: 90