MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP CNV GLEN BASE NON HA; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product code: phx.Concomitant medical products: catalog #: 180554, comp lk scr 3.5hex 4.75x35 st, lot # 700070.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the screw was thrown out.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04201.

Event Description

It was reported during a total shoulder antroplasty, the comprehensive locking screw was sitting proud after implanting the convertible glenoid.The screw would not advance any further without stripping the head.This locking screw was removed and replaced with a nonlocking screw to avoid any issue with the liner engaging the baseplate properly.No additional information is available from the event.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

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

• Brand Name: COMP CNV GLEN BASE NON HA
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9510375
• MDR Text Key: 194139743
• Report Number: 0001825034-2019-05710
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00887868343797
• UDI-Public: (01)00887868343797
• Combination Product (y/n): N
• PMA/PMN Number: K130390
• 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: 01/15/2020

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: 110005273
• Device Lot Number: 002820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE