MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-11-27 for ANTHOLOGY HIGH OFFSET FEMORAL STEM SIZE 7 71356107 manufactured by Smith & Nephew, Inc..
Report Number | 1020279-2019-04173 |
MDR Report Key | 9382709 |
Report Source | CONSUMER,OTHER |
Date Received | 2019-11-27 |
Date of Report | 2019-11-27 |
Date of Event | 2013-04-22 |
Date Mfgr Received | 2019-05-29 |
Date Added to Maude | 2019-11-27 |
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 | 3 |
Manufacturer Contact | DR. SARAH FREESTONE |
Manufacturer G1 | SMITH & 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 | ANTHOLOGY HIGH OFFSET FEMORAL STEM SIZE 7 |
Generic Name | PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL |
Product Code | JDG |
Date Received | 2019-11-27 |
Catalog Number | 71356107 |
Lot Number | 11FM17364 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SMITH & NEPHEW, INC. |
Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-27 |