MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-04 for PLUS 76535382 manufactured by Smith & Nephew, Inc..
[12018407]
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.
Patient Sequence No: 1, Text Type: N, H10
[21880985]
It was reported that revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5
[22010652]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2014-00130 |
| MDR Report Key | 3658519 |
| Report Source | 07 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-03-03 |
| Date of Event | 2014-01-22 |
| Date Mfgr Received | 2014-03-03 |
| Date Added to Maude | 2014-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MELANIE TRAVIS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | TUTTLINGEN TN 38116 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUS |
| Generic Name | FEMORAL COMPONENT |
| Product Code | LPF |
| Date Received | 2014-03-04 |
| Catalog Number | 76535382 |
| Lot Number | 06GT99728 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 GM 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 71339048 | 1. Hospitalization | 2014-03-04 |