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

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).Other device used: catalog #unk, unknown zimmer reverse shoulder glenosphere, lot #unk.This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to pain.The surgeon suspected the stem may be loose.

Manufacturer Narrative

Operative notes were requested however none provided.Relevant medical history and adherence to rehabilitation protocol are unknown.No devices or photos were received; therefore the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed.These products were used for treatment.The complaint history for these products could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices are an approved and compatible combination.A definitive root cause cannot be determined with the information provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer biomet considers the investigation closed.

• Brand Name: UNKNOWN ZIMMER REVERSE SHOULDER STEM
• 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: 5350119
• MDR Text Key: 35242247
• Report Number: 1822565-2016-00034
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• 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?: No
• Date Manufacturer Received: 03/17/2016
• 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