MAUDE Adverse Event Report: ZIMMER INC UNKNOWN BIGLIANI/FLATOW GLENOID; SHOULDER PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that glenoid radiolucent lines were noted in 5 patients.This includes 3 patients with grade 3 loosening, 1 with grade 2 and 1 with grade 1.

Manufacturer Narrative

No device or photos were received; therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot number is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Product history search cannot be completed and compatibly cannot be verified since the part and lot number is unknown.Patient¿s adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN BIGLIANI/FLATOW GLENOID
• 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: 5488914
• MDR Text Key: 39975900
• Report Number: 1822565-2016-00614
• 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
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• 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?: Yes
• Date Manufacturer Received: 07/07/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other