MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-31 for TANDEM 71322045 manufactured by Smith And Nephew, Inc.
[2001629]
It was reported that a revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5
[9019079]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2011-00180 |
| MDR Report Key | 2108387 |
| Report Source | 07 |
| Date Received | 2011-05-31 |
| Date of Report | 2011-05-31 |
| Date of Event | 2011-05-16 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2011-06-01 |
| 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 PHILLIP EMMERT |
| Manufacturer Street | 1450 E. BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995296 |
| Manufacturer G1 | SMITH AND NEPHEW, INC |
| Manufacturer Street | 1450 BROOKS ROAD |
| 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 | TANDEM |
| Generic Name | ACETABULAR SHELL |
| Product Code | JDD |
| Date Received | 2011-05-31 |
| Catalog Number | 71322045 |
| Lot Number | 09JM11871 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH AND NEPHEW, INC |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-05-31 |