MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-19 for BILOX BIOLOX CERAMIC LINER 36MM 76539155 manufactured by Germany Manufacturing Site.
[20242621]
It was reported that revision was performed, due to a fracture of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010764-2009-00500 |
| MDR Report Key | 1346770 |
| Report Source | 07 |
| Date Received | 2009-03-19 |
| Date of Report | 2009-03-19 |
| Date of Event | 2009-02-18 |
| Date Facility Aware | 2009-02-20 |
| Report Date | 2009-02-23 |
| Date Mfgr Received | 2009-02-20 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2009-03-25 |
| 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 RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | GERMANY MANUFACTURING SITE |
| Manufacturer Street | ALEMANNENSTRASSE 14 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BILOX |
| Generic Name | LINER / LMN |
| Product Code | LMN |
| Date Received | 2009-03-19 |
| Returned To Mfg | 2009-03-06 |
| Model Number | BIOLOX CERAMIC LINER 36MM |
| Catalog Number | 76539155 |
| Lot Number | 08BT17195 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GERMANY MANUFACTURING SITE |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-03-19 |