MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 3; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX3SS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Joint Impingement (4834)
Date of Event	10/13/2025
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
Subject: (b)(6) shoulder id study (b)(6) 2025.Post-operative adverse event: scapular notching.Narrative: patient was found to have a loose humeral component in the setting of early scapular notching at an unscheduled visit 1.5 years after surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned.Since x-ray was provided, the opinion of the medical expert was sought and stated as follows: i was able to check the early postoperative images as well and they look good.Already at 3 months follow up some bone resorption on the lateral proximal part of the humerus appears (that is not the location for notching related bone loss).The direction of the images both at one year and at the additional visit do not show the scapular neck.Therefore, assessment of notching is not possible.On the images as such no notching can be seen.At the time of the unscheduled visit, subsidence of the humeral component is seen with closer proximity of the humeral bone medially to the scapular neck.This may lead to a secondary higher risk of notching.The study device is intact and well-fixed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject: (b)(6).Shoulder id study.(b)(6) 2025.Post-operative adverse event: scapular notching.Narrative: patient was found to have a loose humeral component in the setting of early scapular notching at an unscheduled visit 1.5 years after surgery.

• Brand Name: PERFORM HUMERAL STEM SZ 3
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23525656
• Report Number: 0001649390-2025-00808
• Device Sequence Number: 15738344
• Product Code: PAO
• UDI-Device Identifier: 00846832085477
• UDI-Public: 00846832085477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• 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): 02/12/2026

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: DWX3SS
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 83 KG