MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-11-29 for ACETLR CUP HAP 58MM W/ IMPTR 74120158 manufactured by Smith & Nephew Orthopaedics Ltd.
Report Number | 3005975929-2019-00421 |
MDR Report Key | 9391991 |
Report Source | FOREIGN,OTHER |
Date Received | 2019-11-29 |
Date of Report | 2019-11-29 |
Date of Event | 2010-08-26 |
Date Mfgr Received | 2019-11-01 |
Device Manufacturer Date | 2008-06-05 |
Date Added to Maude | 2019-11-29 |
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 ORTHOPAEDICS LTD |
Manufacturer Street | AURORA HOUSE SPA PARK |
Manufacturer City | LEAMINGTON SPA CV313HL |
Manufacturer Country | UK |
Manufacturer Postal Code | CV31 3HL |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ACETLR CUP HAP 58MM W/ IMPTR |
Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING |
Product Code | NXT |
Date Received | 2019-11-29 |
Catalog Number | 74120158 |
Lot Number | 088776 |
Device Expiration Date | 2013-05-31 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SMITH & NEPHEW ORTHOPAEDICS LTD |
Manufacturer Address | AURORA HOUSE SPA PARK LEAMINGTON SPA CV313HL UK CV31 3HL |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-29 |