SIDUS HUMERAL HEAD EXTREMITIES IMPL WIN GEN N/A UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-28 for SIDUS HUMERAL HEAD EXTREMITIES IMPL WIN GEN N/A UNKNOWN manufactured by Zimmer Gmbh.

MAUDE Entry Details

• Report Number: 0009613350-2020-00153
• MDR Report Key: 9892507
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-03-28
• Date of Report: 2020-03-27
• Date of Event: 2019-10-09
• Date Mfgr Received: 2019-10-11
• Date Added to Maude: 2020-03-28
• 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: MS. CHRISTINA ARNT
• Manufacturer Street: 56 E. BELL DR.
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal: 46582
• Manufacturer Phone: 5745273773
• Manufacturer G1: ZIMMER GMBH
• Manufacturer Street: SULZER ALLEE 8 SULZER INDUSTRIE PARK
• Manufacturer City: WINTERTHUR 8404
• Manufacturer Country: SZ
• Manufacturer Postal Code: 8404
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SIDUS HUMERAL HEAD EXTREMITIES IMPL WIN GEN
• Generic Name: SIDUS HUMERAL HEAD
• Product Code: KWS
• Date Received: 2020-03-28
• Model Number: N/A
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER GMBH
• Manufacturer Address: SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2020-03-28