MAUDE Adverse Event Report: TORNIER INC UNKNOWN PERFORM REVERSED GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number UNK_WTB

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

Patient Problem Limb Fracture (4518)

Event Date 10/15/2023

Event Type  Injury  

Event Description

A revision surgery was performed on (b)(6) 2023 by the surgeon, using the blueprint planning feature (case id: (b)(4)).As reported by the rep, "as far as i remember it was a periprosthetic fracture of a tornier flex with perform reversed.".

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 in a supplemental report.

Manufacturer Narrative

Please note correction to b5 (executive summary).It was initially reported in the event that this was periprosthetic fracture of a tornier flex with perform reversed.In a tornier flex with perform reversed it includes the following implants: stem + tray + insert (flex) and baseplate + glenosphere (perform reversed).However, after receiving additional information from the surgeon, it was confirmed that the implants were tornier flex + perform keeled glenoid.In a tornier flex with perform keeled glenoid, it includes the following implants: stem + humeral head (flex) and keeled glenoid (perform anatomic).Therefore, the reported device in this complaint and mfr report #: 0001649390-2024-00007 is no longer applicable and the respective complaint will be cancelled.

Event Description

A revision surgery was performed on 2023 (b)(6) by the surgeon, using the blueprint planning feature (case id: (b)(4).As reported by the rep, "as far as i remember it was a periprosthetic fracture of a tornier flex with perform reversed." corrections were made by the rep after talking to the surgeon: "the fracture was on the humerus only, and the implants were tornier flex + perform keeled glenoid." the surgeon confirmed the revision for revision is "periprosthetic humeral fracture".

• Brand Name: UNKNOWN PERFORM REVERSED GLENOSPHERE
• 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: 18473577
• MDR Text Key: 332374106
• Report Number: 0001649390-2024-00007
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/08/2024
• 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