MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED CTR SCREW 9.5MMX30MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.

Event Description

The implants involved in the failure were from tornier.The glenoid baseplate failed four weeks post-operation, possibly due to a fall.All tornier implants were removed.An update reveals that a 25mm full wedge baseplate with a 30mm 9.5mm central screw was removed, and the failure was not attributed to hardware.

• Brand Name: TORNIER PERFORM REVERSED CTR SCREW 9.5MMX30MM NON STERILE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18908717
• MDR Text Key: 337731489
• Report Number: 0001649390-2024-00115
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832088607
• UDI-Public: 00846832088607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWJ230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 03/14/2024
• 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