MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-12 for ACCLAIM LINKED POLY HUM YOKE 172285000 manufactured by Depuy Orthopaedics, Inc. 1818910.
Report Number | 1818910-2019-95777 |
MDR Report Key | 8691444 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2019-06-12 |
Date of Report | 2019-05-22 |
Date of Event | 2019-05-22 |
Date Mfgr Received | 2019-07-17 |
Device Manufacturer Date | 2005-04-25 |
Date Added to Maude | 2019-06-12 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. KARA DITTY-BOVARD |
Manufacturer Street | 1210 WARD AVENUE |
Manufacturer City | WEST CHESTER PA 193800988 |
Manufacturer Country | US |
Manufacturer Postal | 193800988 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
Manufacturer City | WARSAW IN 465820988 |
Manufacturer Country | US |
Manufacturer Postal Code | 465820988 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ACCLAIM LINKED POLY HUM YOKE |
Generic Name | ACCLAIM ELBOW IMPLANT : ELBOW HUMERAL YOKE |
Product Code | JDB |
Date Received | 2019-06-12 |
Catalog Number | 172285000 |
Lot Number | ZP8B41000 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-06-12 |