UNKNOWN HIP ACETABULAR POLY/METAL HEMI UNK HIP ACETABULARPOLY/METAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-16 for UNKNOWN HIP ACETABULAR POLY/METAL HEMI UNK HIP ACETABULARPOLY/METAL manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

• Report Number: 1818910-2019-104658
• MDR Report Key: 9071066
• Date Received: 2019-09-16
• Date of Report: 2019-08-23
• Date of Event: 2019-08-23
• Date Mfgr Received: 2019-10-04
• Date Added to Maude: 2019-09-16
• 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 DR.
• 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

Device Details

• Brand Name: UNKNOWN HIP ACETABULAR POLY/METAL HEMI
• Generic Name: HIP ACETABULAR POLY/METAL HEMI
• Product Code: KWB
• Date Received: 2019-09-16
• Catalog Number: UNK HIP ACETABULARPOLY/METAL
• Lot Number: UNKNOWN
• 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 US
• Manufacturer Address: 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-09-16