MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-07-31 for ALUMINA OR71338450 manufactured by Smith & Nephew, Inc. Brooks Manufacturing Site.
[1606804]
It was reported that revision surgery was performed due to pain.
Patient Sequence No: 1, Text Type: D, B5
[8863215]
The purpose of this investigation was to evaluate the alumina ceramic femoral head and alumina ceramic liner. The as-received components were examined visually and microscopically. No destructive testing was carried out. Roughening and metal transfer was observed on the articulating surface of the alumina ceramic femoral head. Sem/edxa spectrum analysis of the metal transfer regions on the articulating surface of the alumina ceramic femoral head revealed signs of titanium, iron, and chromium. Sem image analysis of the roughened regions of the alumina ceramic femoral head revealed signs of grain pull-out. Metal transfer was observed on the superior surface of the rim and the articulating surface of the liner. Sem/edxa image and spectrum analysis of the superior surface of the rim revealed signs of titanium. Sem/edxa spectrum analysis of the superior surface of the rim revealed signs of iron and chromium. Sem/edxa spectrum analysis of the articulating surface of the liner near the rim revealed signs of iron, chromium and nickel. The metal transfer observed on the taper surfaces of the alumina ceramic liner due to contact with the acetabular shell was non-uniform. The majority of the metal transfer observed on the articulating surface of the femoral head and liner was stainless steel. This was likely due to contact by the head or liner with a stainless steel object and subsequent articulation between the head and liner. There were signs of titanium transfer on the femoral head and superior surface of the liner which was likely due to contact between the femoral head and titanium shell and subsequent contact with the liner. The grain pull-out observed on the femoral head was likely due to the articulation of the two components in the metal transfer region. The metal transfer due to contact between the taper surfaces of the liner and the shell was not uniform which suggests the liner was not fully taper locked with the shell.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2010-00210 |
| MDR Report Key | 1778618 |
| Report Source | 07 |
| Date Received | 2010-07-31 |
| Date of Report | 2011-02-04 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2010-06-28 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2010-08-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. JENNIFER NELMS |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995451 |
| Manufacturer G1 | SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALUMINA |
| Generic Name | CERAMIC LINER |
| Product Code | LPF |
| Date Received | 2010-07-31 |
| Returned To Mfg | 2010-06-28 |
| Catalog Number | OR71338450 |
| Lot Number | 04LM18770 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-07-31 |