MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETABULAR CUP

Catalog Number 74120156

Device Problem Corroded (1131)

Patient Problems Edema (1820); Erythema (1840); Fall (1848); Swelling (2091)

Event Date 04/08/2014

Event Type  Injury  

Event Description

Swelling revision surgery performed due to swelling of right leg and small fluid pocket in right groin.Patient had falls in late november/ early (b)(6) 2011 and (b)(6) 2012 (fell backwards, twisted to save hip) and 2 months after (b)(6) fall developed a painless swelling of right leg all over, worse around the calf and ankle of right foot.Doppler confirmed no dvt.Whole blood metal ion testing done in (b)(6) in (b)(6) 2013: cobalt=5.1ppb, chromium=3.31ppb.On examination on (b)(6) 2014, it was noted there was swelling of the right lower limb, worse below knee, redness and pitting oedema, and a palpable swelling firm around 10cm wide.X-rays revised.Revision surgery noted there was fluid in the hip joint and this was sent for culture.The synovium was slightly discoloured, possibly with metal.The bearing looed pristine, but when the femoral head was removed there was corrosion at the head/neck taper.X-rays taken on: (b)(6) 2008, pre op thr.(b)(6) 2014, pre-op revision.(b)(6) 2014, post-op revision.

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW; aurora house; spa park; leamington spa CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV34 6WG; UK CV34 6WG
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3844719
• MDR Text Key: 16801349
• Report Number: 3005477969-2014-00352
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2014

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
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 08DW16574 008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MODULAR SLEEVE, # 74222100, LOT # 08CW16013; MODULAR HEAD, # 74222150, LOT # 08EW17063 011
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR