MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-08 for DURAMER ADVANTIM POST. STAB. LSI TIBIAL INSERT 1890-3312 manufactured by .
| Report Number | 1043534-1997-00114 |
| MDR Report Key | 111844 |
| Date Received | 1997-08-08 |
| Date of Event | 1997-06-12 |
| Date Mfgr Received | 1997-07-10 |
| Date Added to Maude | 1997-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAMER ADVANTIM POST. STAB. LSI TIBIAL INSERT |
| Generic Name | KNEE COMPONENT-DEVICE 2 |
| Product Code | KRP |
| Date Received | 1997-08-08 |
| Model Number | NA |
| Catalog Number | 1890-3312 |
| Lot Number | A007478 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 109812 |
| Baseline Brand Name | DURAMER ADVANTIM POST STAB LSI TIBIAL INSERT |
| Baseline Generic Name | KNEE COMPONENT |
| Baseline Catalog No | 1890-3312 |
| Baseline Device Family | K J 888.3560 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-08 |