MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-05 for BIOLOX manufactured by Smith & Nephew, Inc., Brooks Manufacturing Site.
[1323773]
It was reported that revision surgery was performed due to a fracture of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2010-00025 |
| MDR Report Key | 1599840 |
| Report Source | 07 |
| Date Received | 2010-02-05 |
| Date of Report | 2010-02-05 |
| Date of Event | 2009-12-10 |
| Date Mfgr Received | 2009-12-10 |
| Date Added to Maude | 2010-02-18 |
| 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. MELANIE TRAVIS |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | BROOKS MANUFACTURING SITE |
| Manufacturer Street | 1450 BROOKS RD. |
| 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 | BIOLOX |
| Generic Name | FEMORAL HEAD / LPF |
| Product Code | LPF |
| Date Received | 2010-02-05 |
| Catalog Number | NI |
| Lot Number | T03850001 |
| 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., BROOKS MANUFACTURING SITE |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-02-05 |