MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-19 for CONQUEST FN LCK PL 3H L 127MM 75807003L manufactured by Smith & Nephew, Inc..
[180786048]
It was reported that revision was performed due to conquest-fracture collapsed (so it was converted to total hip). The patient did not fall but was complaining of pain. They found in x-rays broken screws.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1020279-2020-00628 |
MDR Report Key | 9727250 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-02-19 |
Date of Report | 2020-02-19 |
Date of Event | 2018-06-03 |
Date Mfgr Received | 2020-02-11 |
Device Manufacturer Date | 2016-06-09 |
Date Added to Maude | 2020-02-19 |
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 Street | 1450 BROOKS ROAD |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal | 38116 |
Manufacturer Phone | 0447940038 |
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 | CONQUEST FN LCK PL 3H L 127MM |
Generic Name | DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT |
Product Code | JDO |
Date Received | 2020-02-19 |
Model Number | 75807003L |
Catalog Number | 75807003L |
Lot Number | 16BTM0011A |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | R |
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 | 2020-02-19 |