MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PLUS; FEMORAL COMPONENT

Catalog Number 76535382

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/22/2014

Event Type  Injury  

Manufacturer Narrative

The purpose of this investigation was to examine the as-received components.The returned hip stem, ceramic femoral head, acetabular liner, and reflection acetabular shell were examined visually.No destructive testing was carried out.The stem had signs of burnishing and fretting along the length of the stem.The ceramic femoral head had signs of metal transfer and material removal.The reflection acetabular shell had signs of burnishing on the taper locking surface which was likely due to contact with ceramic femoral head or the hip stem following the fracture of the liner.The ceramic acetabular liner was fractured in two pieces and a portion of the rim was missing from one of the fragments.It is unclear the cause of the fractured liner.

Event Description

It was reported that revision surgery was performed.

• Brand Name: PLUS
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116 ; GM 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; tuttlingen TN 38116 ; GM 38116
• Manufacturer Contact: melanie travis ; 1450 brooks road; memphis, TN 38116 ; 9013996233
• MDR Report Key: 3658519
• MDR Text Key: 12018407
• Report Number: 1020279-2014-00130
• Device Sequence Number: 1
• Product Code: LPF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2014

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 Catalogue Number: 76535382
• Device Lot Number: 06GT99728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 03/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71339048, (B)(4), 71332800, (B)(4), 76539422
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR