MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A planned revision surgery was performed by the surgeon using the blueprint planning feature.Reason for revision - soft tissue interposition and the implant and/or impingement of the lesser tuberosity on the coracoid.
Additional Manufacturer Narrative
Additional information has been requested and, if received, will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event was confirmed based on the formal medical expert opinion.The device inspection was not possible as the product was not returned for investigation.A review of the operative notes by the medical expert stated: ¿the surgeon reported that a revision surgery was performed for a painful left shoulder, with no specific preoperative indication other than persistent pain.During the exploratory revision, the fixation and positioning of both the humeral component and the glenoid baseplate were evaluated.The surgeon confirmed that both components were well positioned and securely fixed to the bone.To fully assess the stability of the glenoid baseplate, the four peripheral screws were removed, which necessitated the placement of new screws upon reassembly.Based on intraoperative findings, the surgeon concluded that the likely cause of the patient¿s pain was an oversized glenosphere combined with impingement of the greater tuberosity against the undersurface of the acromion.Consequently, the glenosphere was downsized, and a portion of bone from the greater tuberosity was resected to alleviate impingement.¿ the device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the investigation and formal medical expert opinion, the root cause is attributed to a patient related issue leading to pain due to impingement.The pain was likely due to an oversized glenosphere and impingement of the greater tuberosity.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
A planned revision surgery was performed by the surgeon using the blueprint planning feature.Reason for revision - soft tissue interposition and the implant and/or impingement of the lesser tuberosity on the coracoid.

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 25MM
• 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: 24303803
• Report Number: 0001649390-2026-00112
• Device Sequence Number: 12047769
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: DWJ502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 59 YR
• Patient Sex: Male