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

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing a rash around the incision and breaking out.

Manufacturer Narrative

Operative notes and x-rays were requested however none provided.The devices remain implanted therefore no devices or photos were returned.The devices part numbers and lot numbers were not provided therefore their device history records could not be reviewed.The devices were used for treatment.Due to the lack of part numbers and lot numbers a complaint search could not be performed.Device compatibility could not be confirmed due to the lack of part numbers.With the provided information an exact cause could not be determined.

• Brand Name: UNKNOWN ZIMMER SHOULDER
• 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: 5261086
• MDR Text Key: 32516193
• Report Number: 1822565-2015-02494
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• 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?: No
• Date Manufacturer Received: 02/05/2016
• 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): Other