MAUDE Adverse Event Report: TORNIER INC PERFORM FX STEM SZ 8S L. 130MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	PFX08130S
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	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6).Perform fracture study.Delayed union: radiologist noted a delayed union; bone not yet consolidated at 6 month mark".
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.
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: the subject had a severely displaced fracture dislocation of the proximal humerus.The patient was treated with a perform fracture stem in a hemiarthroplasty configuration.The greater tuberosity was reattached as good as was achievable.At 6-months, the image shows a posterior located greater tuberosity that has not yet fully consolidated (but most likely it will).There are no images at 1-year available (yet).In the character of displaced proximal humeral fractures, bone fragments can lose their vascularity during the trauma, jeopardizing/slowing down fracture healing.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 noted a delayed union; bone not yet consolidated at 6 month mark".

• Brand Name: PERFORM FX STEM SZ 8S 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: 21718722
• Report Number: 0001649390-2025-00183
• Device Sequence Number: 13116372
• Product Code: PHX
• UDI-Device Identifier: 00846832092239
• UDI-Public: 00846832092239
• 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: PFX08130S
• Device Lot Number: 7999AZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• 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: 10/14/2023
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 64 KG