MAUDE Adverse Event Report: UNKNOWN ZIMMER B/F HUMERAL STEM; SHOULDER PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other devices used: unknown zimmer b/f glenoid,.Unknown zimmer b/f humeral head.This report will be amended when our investigation is complete.

Event Description

It is reported the patient had an infection reported in the operative shoulder.

• Brand Name: UNKNOWN ZIMMER B/F HUMERAL STEM
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5033034
• MDR Text Key: 24162700
• Report Number: 1822565-2015-01597
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• 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: 85