MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-06-06 for ACHIEVECAS NOT EXACT manufactured by Smith & Nephew, Inc., Orthopaedic Div..
[486562]
Because the instrument would not function properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2006-00523 |
| MDR Report Key | 723136 |
| Report Source | 07 |
| Date Received | 2006-06-06 |
| Date of Report | 2006-05-26 |
| Date of Event | 2006-05-19 |
| Date Mfgr Received | 2006-05-26 |
| Date Added to Maude | 2006-06-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MRS MELANIE TRAVIS, REG COMPLIANCE |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | SMITH & NEPHEW INC. |
| 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 | ACHIEVECAS |
| Generic Name | SPHERES |
| Product Code | NVR |
| Date Received | 2006-06-06 |
| Returned To Mfg | 2006-05-28 |
| Model Number | NA |
| Catalog Number | NOT EXACT |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 712213 |
| Manufacturer | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
| Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 38116 US |
| Baseline Brand Name | GENESIS II |
| Baseline Generic Name | FEMORAL COMPONENT |
| Baseline Model No | NOT EXACT |
| Baseline Catalog No | 71421127 |
| Baseline ID | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-06-06 |