MAUDE Adverse Event Report: UNKNOWN ZIMMER BIGLIANI/FLATOW HUMERAL STEM; SHOULDER PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.(b)(4).Other devices used: catalog #unknown, unknown standard pegged white bigliani/flatow glenoid , lot #unknown catalog #unknown, unknown bigliani/flatow humeral head, lot #unknown this report will be amended when our investigation is complete.

Event Description

It is reported that the patient felt a sharp pain in her shoulder after lifting an 8 pound weight.

• Brand Name: UNKNOWN ZIMMER BIGLIANI/FLATOW HUMERAL STEM
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5015623
• MDR Text Key: 23479361
• Report Number: 1822565-2015-01513
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 84