MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL GLENOID COMPONENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Investigation in progress.Device not returned.

Event Description

Patient underwent an initial right shoulder procedure on (b)(6) 2017.Subsequently, the patient was revised due to rotator cuff failure on (b)(6) 2018.The original implants were removed and zimmer biomet's comprehensive reverse shoulder was inserted.

Manufacturer Narrative

As stated in the complaint description, the patient underwent revision surgery due to rotator cuff surgery.No report of any implant failure, moreover the attached x-ray shows the implant intact in the shoulder (no sign of device breakage).No device was returned for evaluation, therefore only a device history review was performed.Device history records were reviewed for the part number (b)(4) and lot number 63364705 of trabecular metal glenoid component and no deviations or anomalies were found.A review of the implant's manufacturing record indicates that it was manufactured to specification.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

Patient underwent an initial right shoulder procedure on (b)(6) 2017.Subsequently, the patient was revised due to rotator cuff failure on (b)(6) 2018.The original implants were removal and zimmer biomet comprehensive reverse shoulder were inserted.Tm glenoid component is the only tmt design control part.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

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

• Brand Name: TRABECULAR METAL GLENOID COMPONENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7804440
• MDR Text Key: 117846911
• Report Number: 3005751028-2018-00046
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00432604600
• Device Lot Number: 63364705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention