AS INVERSE HUMERAL CUP, OFF CENTER 01.04223.106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-11-04 for AS INVERSE HUMERAL CUP, OFF CENTER 01.04223.106 manufactured by Zimmer Gmbh.

Event Text Entries

[1307253] It was reported that implant was revised for loosening of the glenoid component.
Patient Sequence No: 1, Text Type: D, B5

[8421032] This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9613350-2009-00563
• MDR Report Key: 1523532
• Report Source: 05,08
• Date Received: 2009-11-04
• Date of Report: 2009-10-08
• Date of Event: 2009-10-08
• Date Facility Aware: 2009-10-08
• Report Date: 2009-10-08
• Date Mfgr Received: 2009-10-08
• Date Added to Maude: 2009-11-12
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DALE MILLER
• Manufacturer Street: P.O. BOX 708
• Manufacturer City: WARSAW IN 465810708
• Manufacturer Country: US
• Manufacturer Postal: 465810708
• Manufacturer Phone: 5742676131
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AS INVERSE HUMERAL CUP, OFF CENTER
• Generic Name: ANATOMICAL SHOULDER INVERSE/REVERSE
• Product Code: KYM
• Date Received: 2009-11-04
• Catalog Number: 01.04223.106
• Lot Number: UNKNOWN
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER GMBH
• Manufacturer Address: SULZER ALLEE 8 WINTERTHUR 8404 SZ 8404

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2009-11-04