MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSRT SZ 3/4 42MM DIA -2MM 55% VE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS1022306
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The perform -2 poly did not properly seat into the 3 perform standard stem.A second one was used and it didn't seat again.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Upon further review of the risk assessment, this complaint was re-evaluated and determined to be non-reportable.No indication of patient impact was identified, and the procedure was completed successfully.Therefore, the initial mdr should not have been reported.
Event or Problem Description
The perform -2 poly did not properly seat into the 3 perform standard stem.A second one was used and it didn't seat again.

• Brand Name: PERFORM REV INSRT SZ 3/4 42MM DIA -2MM 55% VE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 24402252
• Report Number: 0001649390-2026-00173
• Device Sequence Number: 9730483
• Product Code: KWS
• UDI-Device Identifier: 00846832094233
• UDI-Public: 00846832094233
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K241878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ARS1022306
• Device Lot Number: AZ4322341081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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
• Patient Sex: Unknown