MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2006-06-12 for SPECTRON EF 71313001 manufactured by Smith & Nephew Inc., Orthopaedic Div..
[493779]
It was reported that pt underwent revision surgery due to loosening.
Patient Sequence No: 1, Text Type: D, B5
[7843399]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2006-00530 |
| MDR Report Key | 724453 |
| Report Source | 03 |
| Date Received | 2006-06-12 |
| Date of Report | 2006-06-09 |
| Date Mfgr Received | 2006-06-09 |
| Date Added to Maude | 2006-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR NICHOLAS TABRIZI, SPECIALIST |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996017 |
| Manufacturer G1 | SMITH & NEPHEW INC. |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRON EF |
| Generic Name | FEMORAL COMPONENT |
| Product Code | JDD |
| Date Received | 2006-06-12 |
| Model Number | NA |
| Catalog Number | 71313001 |
| Lot Number | NOT EXACT |
| ID Number | NOT EXACT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 713910 |
| Manufacturer | SMITH & NEPHEW INC., ORTHOPAEDIC DIV. |
| Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-06-12 |