MAUDE Adverse Event Report: SMITH AND NEPHEW ACETABULAR CUP

Device Problems Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 09/13/2007

Event Type  Injury  

Event Description

Left hip metal-on-metal resurfacing surgery performed (b)(6) 2007.According to the operative report, smith & nephew acetabular cup (56 mm) and femoral head (50 mm) were implanted.Hip has become increasingly painful, with popping clicking and "squeaking".Pain and noises are worsening.In (b)(6) 2014 consulted with another orthopedic surgeon.X-rays showed deterioration of the joint.Blood test for cobalt and chromium levels were "off the charts" according to the surgeon.Surgeon recommended "revision" surgery, to occur in (b)(6) 2015.I was never notified by the original surgeon of the potential for deterioration of the possibility of cobalt/chromium poisoning.

• Brand Name: ACETABULAR CUP
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 4284320
• MDR Text Key: 5299259
• Report Number: MW5039287
• 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: 11/21/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 68