MAUDE Adverse Event Report: TORNIER INC PERFORM 10 DEG 55% INSERT VE SZ3/4 39 MM +3; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWT4393
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	07/07/2025
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) perform fracture study instability ¿ dynamic.Subject contacted clinic on (b)(6) 2025 with reports of atraumatic instability and pain.She was seen in clinic on (b)(6) 2025.X-rays and ct scan showed mild notching but no other abnormalities.No documented dislocations.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned, but evidence based on images was provided, which matches the alleged failure.A device inspection was not possible since the affected device was not returned for investigation.Since x-rays/ct scan and data were provided, the opinion of a medical expert was sought and stated as follows: the mild notching is confirmed in the provided image only the glenosphere and liner (insert pe) are planned to be exchanged in this case because this is typically done in cases of dynamic instability (subluxations, no dislocation), to increase the soft tissue tension.Insufficient soft tissue tension, most likely patient related factors.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.Based on investigation, the root cause was most likely attributed to a patient related issue.The event was caused by a soft tissue tension insufficiency (dynamic instability).If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject: (b)(6) perform fracture study.Instability ¿ dynamic.Subject contacted clinic on (b)(6) 2025 with reports of atraumatic instability and pain.She was seen in clinic on (b)(6) 2025.X-rays and ct scan showed mild notching but no other abnormalities.No documented dislocations.

• Brand Name: PERFORM 10 DEG 55% INSERT VE SZ3/4 39 MM +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: 23654534
• Report Number: 0001649390-2025-00872
• Device Sequence Number: 13268711
• Product Code: PAO
• UDI-Device Identifier: 00846832078639
• UDI-Public: 00846832078639
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/16/2026

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: DWT4393
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 76 KG