MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 2; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX2SS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/05/2024
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
Subject: (b)(6).Perform humeral system study (phs).Unexpected pain not related to surgical recovery.Subject reported pain at their study visit.The pain may be related to overuse following their contralateral shoulder replacement on (b)(6) 2024.An ultrasound on (b)(6) 2024 demonstrated no retracted rotator cuff muscle.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was implanted and hence not returned for evaluation.The device inspection was not possible as the product was implanted and hence not returned for investigation.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.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject: (b)(6).Perform humeral system study (phs).Unexpected pain not related to surgical recovery.Subject reported pain at their study visit.The pain may be related to overuse following their contralateral shoulder replacement on (b)(6) 2024.An ultrasound on (b)(6) 2024 demonstrated no retracted rotator cuff muscle.

• Brand Name: PERFORM HUMERAL STEM SZ 2
• 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: 23642302
• Report Number: 0001649390-2025-00845
• Device Sequence Number: 18655175
• Product Code: PAO
• UDI-Device Identifier: 00846832085439
• UDI-Public: 00846832085439
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: DWX2SS
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/05/2026
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 93 KG