MAUDE Adverse Event Report: ZIMMER BIOMET TMT TRABECULAR METAL GLENOID COMPONENT 46 MM; PROSTHESIS, SHOULDER

Model Number 00432604600

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.In complete device return.Device history records were reviewed for the glenoid component and no deviations or anomalies were found.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

Event Description

It was reported that a patient underwent an initial shoulder procedure on unknown date.Subsequently the revision procedure was performed on (b)(6) 2018 due to glenoid separation.The glenoid was removed and the implant had sheared at the junction of the poly and tm.It did not appear that the product separated at the time of the revision surgery but subsequent to the primary surgery.Also noted a small layer of cement on the peripheral aspect of the glenoid.Stem used was the bf stem.Glenoid component is the only tmt design control part.

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.Returned images of the device identified that the baseplate was severed from the keel.There was no evidence to the cause of the fracture.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the event could not be determined.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: TRABECULAR METAL GLENOID COMPONENT 46 MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 8066289
• MDR Text Key: 127056744
• Report Number: 3005751028-2018-00063
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 00432604600
• Device Lot Number: 61326715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention