MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PRESS FIT SHORT POST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ001
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the patient had orif proximal humerus converted to an augmented rsa, the aseptic loosening contributed by suboptimal seating of the baseplate, bone quality was good.No further information was provided.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation, and no other evidence was provided to confirm the alleged issue.A device inspection was not possible since the affected device was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any further information is provided the complaint report will be updated.
Event or Problem Description
It was reported that, the patient had orif proximal humerus converted to an augmented rsa, the aseptic loosening contributed by suboptimal seating of the baseplate, bone quality was good.No further information was provided.
Additional Manufacturer Narrative
The reported event could not be confirmed based on the medical expert opinion on the available radiographs.The device inspection was not possible as the product was not returned for investigation.A formal medical opinion was sought, which concluded a definitive opinion could not be sought because the single low resolution image does not adequately show the implant¿bone interface of the subject component on the glenoid side.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.A review of the labelling did not indicate any abnormalities.Based on the available information, a definitive root cause cannot be established.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED PRESS FIT SHORT POST
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24669332
• Report Number: 0001649390-2026-00301
• Device Sequence Number: 14712888
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: DWJ001
• Device Lot Number: 4076BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2024
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 263 LB