MAUDE Adverse Event Report: TORNIER INC PERFORM FX STEM SZ 14 L. 130MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	PFX14130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6), perform fracture study.Post-operative complications.6-month x-rays demonstrated; delayed bone union, tuberosity migration".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: subject (b)(6).Perform fracture study.Post-operative complications.6-month x-rays demonstrated, delayed bone union, tuberosity migration.
Additional Manufacturer Narrative
The reported event could be confirmed since x-rays were provided for investigation.A device inspection was not possible since the affected device is still implanted.Since x-rays were provided, the opinion of the 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 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 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM FX STEM SZ 14 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 S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21883054
• Report Number: 0001649390-2025-00269
• Device Sequence Number: 8768715
• Product Code: PHX
• UDI-Device Identifier: 00846832092451
• UDI-Public: 00846832092451
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: PFX14130
• Device Lot Number: 3837AZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 65 KG