MAUDE Adverse Event Report: SMITH AND NEPHEW BIRMINGHAM HIP RESURFACING SYSTEM

Lot Number 69501

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Pain (1994); Rash (2033); Toxicity (2333); Osteolysis (2377)

Event Date 02/22/2007

Event Type  Injury  

Event Description

I had smith and nephew, metal on metal.Birmingham hip resurfacing system surgery performed on (b)(6) 2007.I developed a terrible skin rash on front of lower left leg about one year after surgery.Started having bone loss and pain about four years post op.Pain and bone loss continued.Cat scan in (b)(6) 2014, revealed major bone loss on femoral stem, small bone cysts around hip socket, and one golf ball sized bone cyst above hip socket on pelvic bone.I had total hip revision surgery on (b)(6) 2014.My metals patch test on (b)(6) 2014 was positive for cobalt, which is one of the materials used in the birmingham hip resurfacing system.Chromium being the other.I had a metals blood test for cobalt and chromium performed on (b)(6) 2014.Cobalt serum test came back at a 5.4.And the chromium serum test came back at 5.2.

• Brand Name: BIRMINGHAM HIP RESURFACING SYSTEM
• Type of Device: BIRMINGHAM HIP RESURFACING SYSTEM
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 4135289
• MDR Text Key: 4948980
• Report Number: MW5038403
• Device Sequence Number: 2
• 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: 09/28/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 69501
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 96