CORAIL AMT SZ10 135 LOW COL L971310

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-19 for CORAIL AMT SZ10 135 LOW COL L971310 manufactured by Depuy France Sas - 3003895575.

MAUDE Entry Details

• Report Number: 1818910-2019-101537
• MDR Report Key: 8908348
• Date Received: 2019-08-19
• Date of Report: 2019-07-30
• Date of Event: 2019-07-23
• Date Mfgr Received: 2019-10-21
• Device Manufacturer Date: 2018-10-16
• Date Added to Maude: 2019-08-19
• 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
• 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 INTERNATIONAL LTD. 8010379
• Manufacturer Street: ST. ANTHONY'S RD
• Manufacturer City: LEEDS LS118 DT
• Manufacturer Country: UK
• Manufacturer Postal Code: LS11 8 DT
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CORAIL AMT SZ10 135 LOW COL
• Generic Name: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Product Code: JDG
• Date Received: 2019-08-19
• Catalog Number: L971310
• Lot Number: 8890755
• 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 FRANCE SAS - 3003895575
• Manufacturer Address: 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-08-19