MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM REVERSE SHOULDER GLENOSPHERE

Catalog Number 00434904011

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 06/30/2015

Event Type  Injury  

Event Description

It is reported the patient was revised due to a loose glenoid.All products were removed.

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.This report will be amended when our investigation is complete.

Manufacturer Narrative

Other device used: manufactured by zimmer gmbh, (b)(4) - catalog #0104223036, inverse/reverse screw system, lot # unk.Relevant medical history and adherence to rehabilitation protocol are unknown.The provided x-rays were reviewed by a health care professional; their assessment of the imaging states: "the superior glenoid screw is fractured.Radiolucency is present about the inferior glenoid screw and central post consistent with component loosening.On the axillary view, there is ill-defined lucency of the glenoid which may be due to osteolysis.The trabecular metal base plate is angled superiorly and posteriorly with an orientation likely a result of the loosening.The zimmer trabecular metal reverse shoulder system surgical technique states: "evaluate positioning of the base plate by placing the base plate drill guide 1 on the glenoid face.The outer rim of drill guide 1 is the same diameter as the base plate.The outer rim can be rotated relative to the handle to check coverage of the anterior, inferior and posterior edges of the glenoid.The drill guide should be placed so that the outer rim aligns with the inferior rim of the glenoid and is centered in the anterior/posterior direction.This will place the glenosphere at the edge of the inferior glenoid bone." due to the lack of operative notes and immediate postop images it is unknown how the base plate was initially implanted.A definitive root cause cannot be determined with the information provided.

• Brand Name: ZIMMER TM REVERSE SHOULDER GLENOSPHERE
• 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: 4951525
• MDR Text Key: 6636492
• Report Number: 1822565-2015-01329
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00434904011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• 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