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

Catalog Number	PFX09130S
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	03/19/2024
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.A review of the device history is not possible because the lot number was not communicated.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 bone union: bone consolidation not yet completed at 6 months after surgery.Delayed bone union per radiological evaluation dated (b)(6) 2024.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned, but evidences 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: this patient had a displaced proximal humeral fracture that was treated with the implantation of the perform fracture stem in a reverse configuration.At six months the minor tuberosity had healed, but the greater tuberosity did not completely, and after one year some bone resorption of the greater tuberosity took place.This aligns with the character of these displaced fractures where blood supply to bone fragments is easily disrupted during the trauma.Good choice to use a reversed configuration, yielding a good clinical outcome.Implant well-positioned and well-fixed to the bone.Patient-related adverse event, no clinical consequences.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.Based on investigation, the root cause was attributed to a patient related issue (patient conditions).If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "subject: (b)(6).Perform fracture study.Delayed bone union: bone consolidation not yet completed at 6 months after surgery.Delayed bone union per radiological evaluation dated (b)(6) 2024.".

• Brand Name: PERFORM FX STEM SZ 9S 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: 21718469
• Report Number: 0001649390-2025-00179
• Device Sequence Number: 9418901
• Product Code: PHX
• UDI-Device Identifier: 00846832092260
• UDI-Public: 00846832092260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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: PFX09130S
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 50 KG