MAUDE Adverse Event Report: TORNIER INC PERFORM FX STEM SZ 9 L. 130MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	PFX09130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Malunion of Bone (4529)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
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.Delayed union: radiologist notified sponsor of delayed nonunion/bone not yet consolidated at 6 month x-ray.Sponsor subsequently notified site.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned, but evidence were provided based on provided x-rays which match the alleged failure.A device inspection was not possible since the affected device was implanted.Since data and x-rays were provided, the opinion of a medical expert was sought and stated as follows: the subject had a left-sided, 4-part proximal humeral fracture.The x-ray of (b)(6) 2024 shows an intact implant with well repositioned tuberosity fragments.At 6-months post-operative the image shows greater tuberosity has resorbed partially and migrated partly superiorly.The minor tuberosity has not migrated but is not (yet) fully consolidated.Currently there are not yet images available for the 1-year follow-up.I believe its in the character of this 4-part proximal humeral fracture that the tuberosity fragments can become revascularized during the trauma, which may lead to delayed union (determined at 6 months) and possibly non-union (to be determined at 1-year).Medical conditions of the patient (chronic infection, diabetes) may also influence bone healing negatively.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "subject: (b)(4).Perform fracture study.Delayed union: radiologist notified sponsor of delayed nonunion/bone not yet consolidated at 6 month x-ray.Sponsor subsequently notified site.".

• Brand Name: PERFORM FX STEM SZ 9 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: 21718723
• Report Number: 0001649390-2025-00184
• Device Sequence Number: 18496507
• Product Code: PHX
• UDI-Device Identifier: 00846832092307
• UDI-Public: 00846832092307
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/30/2025

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: PFX09130
• Device Lot Number: 3962AZ
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2023
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG