MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Unique identifier (udi) #: (b)(4).

Event Description

It was reported that during a procedure, when the packaging was opened, there were two mini baseplates in the box, and no adaptor.A second mini baseplate box was opened for the adaptor piece.There were no patient consequences as a result.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was returned and reviewed.Two product boxes were returned (the one with the complaint issue and the one that was opened in order to use the taper that was missing).Neither box had a taper adapter in it as one was missing and the other was implanted.Device history record (dhr) was reviewed and a deviation was discovered.Deviation was found at sterile packaging ops due to one piece having no components and the other having 2 pieces.A definitive root cause has not been determined at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE REVERSE GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8038287
• MDR Text Key: 126450043
• Report Number: 0001825034-2018-09856
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000589
• Device Lot Number: 921950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1