MAUDE Adverse Event Report: TORNIER INC PERFORM 45% INSERT VE SZ3/4 39 MM +0; prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Catalog Number	DWS2390
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced recurrent shoulder dislocation/instability following a previously implanted reverse total shoulder arthroplasty.To address the instability, the surgeon performed a revision procedure consisting of an insert exchange, revising the insert from dws2390 to dwr4393.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.

• Brand Name: PERFORM 45% INSERT VE SZ3/4 39 MM +0
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25587128
• Report Number: 0001649390-2026-00613
• Device Sequence Number: 5700802
• Product Code: PAO
• UDI-Device Identifier: 00846832078080
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: DWS2390
• Device Lot Number: CZ592326402400846832078080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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: 67 YR
• Patient Sex: Male