MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 3 PLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWX3PS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned but evidences were provided, based on images which match the alleged failure.A device inspection was not possible since the affected device was not returned for investigation.Since data and images were provided, the opinion of a medical expert was sought and stated as follows the images show clearly that the glenoid construct has tilted posteriorly (backwards).A glenoid component loosening.Poor bone quality is the most likely factor for the component migration.There are no visible issues with the humeral implant which looks well-positioned and well-fixed.These images are not medical grade resolution, so there is room for uncertainty.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine clearly the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A revision surgery was performed on (b)(6) 2025, using the blueprint planning feature.No further information was provided.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
A revision surgery was performed on (b)(6) 2025, using the blueprint planning feature.No further information was provided.

• Brand Name: PERFORM HUMERAL STEM SZ 3 PLUS
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23175554
• Report Number: 0001649390-2025-00674
• Device Sequence Number: 8882954
• Product Code: KWS
• UDI-Device Identifier: 00846832085460
• UDI-Public: 00846832085460
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: DWX3PS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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 Sex: Unknown