MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED CTR SCREW 6.5MMX40MM STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ540
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that; the primary surgery was conducted on (b)(6) 2025.Dislocation of the glenoid component was reported.The impact on pain and range of motion was unclear.The physician commented that the cause was the patient's bone quality issues and the inherently low bone stock in the glenoid cavity.Images of x-ray are unavailable.The revision surgery was conducted on (b)(6) 2026.
Event or Problem Description
It was reported that, the primary surgery was conducted on (b)(6) 2025.Dislocation of the glenoid component was reported.The impact on pain and range of motion was unclear.The physician commented that the cause was the patient's bone quality issues and the inherently low bone stock in the glenoid cavity.Images of x-ray are unavailable.The revision surgery was conducted on (b)(6) 2026.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Device inspection was not possible, as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing-, or design-related problems were found during the investigation.More detailed information about the complaint event, as well as the affected device, must be available in order to determine the root cause of the complaint event.If the device is returned or if any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED CTR SCREW 6.5MMX40MM STERILE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24280098
• Report Number: 0001649390-2026-00104
• Device Sequence Number: 8318479
• Product Code: PHX
• UDI-Device Identifier: 00846832091126
• UDI-Public: (01)00846832091126(11)240704(17)290704(21)AG6981028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ540
• Device Lot Number: AG6981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female