MAUDE Adverse Event Report: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING IMPLANT

Model Number 74122154, 74122548

Device Problem Metal Shedding Debris (1804)

Patient Problems Cyst(s) (1800); Discomfort (2330); Complaint, Ill-Defined (2331); Toxicity (2333); Test Result (2695)

Event Date 08/08/2015

Event Type  Injury  

Event Description

Patient has had right birmingham performed in 2011 with 54 diameter birmingham cup and 48 diameter femoral head.According to the (b)(6) patient did well for the 1st 3 years, but has become uncomfortable and initially, we obtained a cobalt and chromium levels, which were slightly elevated in the 10 range, but the most recent once done on (b)(6) 2015, demonstrate a plasma cobalt of 108 and he is developing myalgias.On (b)(6) 2015, had a revision of this birmingham on the right side to a standard total hip arthroplasty.According to the operative report from the surgeon, the patient had a "large cystic mass with grey tissue consistent with metallosis".

• Brand Name: BIRMINGHAM HIP RESURFACING IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW ; 1450 brooks road ; memphis TN 38116
• MDR Report Key: 5250079
• MDR Text Key: 32198130
• Report Number: 5250079
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: H729741221541H
• UDI-Public: +H729741221541H
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2016
• Device Model Number: 74122154, 74122548
• Device Catalogue Number: 74122154, 74122548
• Device Lot Number: 11AW31376, 08FW17376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2015
• Distributor Facility Aware Date: 09/15/2015
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 09/15/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 77