MAUDE Adverse Event Report: TORNIER INC PERFORM FX STEM SZ 10 L. 130MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	PFX10130
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Inadequate Osseointegration (2646)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction, please refer to h6 (device, clinical, results, method & conclusion) codes.Device was not returned for evaluation, but the reported event could be confirmed with provided x-rays.A device inspection was not possible since the affected device is still implanted.Since data and x-rays were provided, the opinion of a medical expert was sought and stated as follows: the event of greater tuberosity migration is confirmed by the x-ray.This type of adverse event is inherent to the character of displaced proximal humeral fractures, bone fragments can lose their vascularity during the trauma, jeopardizing/slowing down fracture healing.Eventually if they do not heal timely, the pull of rotator cuff tendons will pull the fragment away from the implant.Please note that the suture fixation of the greater tuberosity to the stem may vary amongst surgeon depending on several factors (patient and/or surgeon related).There are no signs of humeral stem loosening and no issues on the glenoid side (there are no signs of any form of device related failure).Based on investigation, the root cause was attributed to patient-related factors.The suture fixation of the greater tuberosity to the stem may vary amongst surgeons depending on several factors.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject: (b)(6).Perform fracture study.Post-operative complication.Migration of greater tuberosity as demonstrated by x-rays taken (b)(6) 2024 during a 6-month visit.Loosening.Reverse procedure.Patient exited study for entering hospice care for lung failure- outcome of ae will remain unknown.
Event or Problem Description
Subject: (b)(6).Perform fracture study.Post-operative complication.Migration of greater tuberosity as demonstrated by x-rays taken (b)(6) 2024 during 6-month visit.Loosening.Reverse procedure.Patient exited study for entering hospice care for lung failure- outcome of ae will remain unknown.

• Brand Name: PERFORM FX STEM SZ 10 L. 130MM
• 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: 23379221
• Report Number: 0001649390-2025-00767
• Device Sequence Number: 18360514
• Product Code: PHX
• UDI-Device Identifier: 00846832092338
• UDI-Public: 00846832092338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• 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: PFX10130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/24/2025
• 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: Other
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 59 KG