MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER TM REVERSE GLENOSPHERE; SHOULDER PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.(b)(4).Other device used: catalog # unknown, unknown zimmer tm reverse humeral stem, lot # unknown; catalog # unknown, unknown zimmer tm reverse poly liner, lot # unknown; catalog # unknown, unknown zimmer tm reverse base plate, lot # unknown.Please reference literature at the following location: (b)(4).Operative notes were not provided.Relevant medical history and adherence to rehabilitation protocol are unknown.No devices or photos were received.The condition of the components is unknown.The part and lot numbers are unknown.The device history records could not be reviewed.The complaint history for these products could not be reviewed.It could not be confirmed if the devices are an approved and compatible combination.Single-use, sterilized devices manufactured or distributed by (b)(4) are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.A definitive root cause cannot be determined with the information provided.The investigation could not verify or identify evidence of product contribution to the reported problem.

Event Description

It has been reported that 1 patient experienced an infection and was revised.

• Brand Name: UNKNOWN ZIMMER TM REVERSE GLENOSPHERE
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5082853
• MDR Text Key: 25988828
• Report Number: 1822565-2015-01902
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• 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: 08/20/2015
• 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): Required Intervention