MAUDE Adverse Event Report: TORNIER INC PERFORM 10 DEG 55% INSERT SZ3/4 42 MM +6; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWR4426
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported that this is the patient¿s third disassociation, and on this occasion the patient claims they woke up in the morning with the joint dislocated.
Event or Problem Description
It was reported that this is the patient¿s third disassociation, and on this occasion the patient claims they woke up in the morning with the joint dislocated.
Additional Manufacturer Narrative
The reported event was not confirmed, since the device was not returned for evaluation and no other evidence were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any further information is provided, the complaint report will be updated.

• Brand Name: PERFORM 10 DEG 55% INSERT SZ3/4 42 MM +6
• Common Device Name: 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22878327
• Report Number: 0001649390-2025-00588
• Device Sequence Number: 20271899
• Product Code: PHX
• UDI-Device Identifier: 00846832085071
• UDI-Public: 00846832085071
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• 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): 11/25/2025

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: DWR4426
• Device Lot Number: AH3963
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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: Unknown