MAUDE Adverse Event Report: TORNIER INC PERFORM 55% INSERT SZ1/2 39 MM +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP3390
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/12/2025
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.The patient called the (b)(6) clinic in (b)(6), (b)(6) 2025 to report he "accidentally picked up a gallon container and held it for about 2 minutes." he reported increasing pain in his left shoulder with movement.He said he felt as if he was "back to square 1" as prior to the shoulder surgery.The surgeon ordered x-rays (b)(6) 2025 and determined they "looked good" and she advised the patient to rest the shoulder.
Event or Problem Description
Subject: (b)(6), shoulder id study.The patient called the (b)(6) 2025 to report he "accidentally picked up a gallon container and held it for about 2 minutes." he reported increasing pain in his left shoulder with movement.He said he felt as if he was "back to square 1" as prior to the shoulder surgery.The surgeon ordered x-rays (b)(6) 2025 and determined they "looked good" and she advised the patient to rest the shoulder.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was 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 further information is provided the complaint report will be updated.

• Brand Name: PERFORM 55% INSERT SZ1/2 39 MM +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 23838737
• Report Number: 0001649390-2025-00956
• Device Sequence Number: 9572417
• Product Code: PHX
• UDI-Device Identifier: 00846832084609
• UDI-Public: 00846832084609
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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: DWP3390
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/18/2025
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 74 KG