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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, two hrs -2 polyethylene inserts (polys) were unable to connect to the hrs centered tray.Both inserts were impacted but did not seat, resulting in their disposal.The centered tray was then removed from use, and a new centered tray was opened; however, both original polys again failed to seat.After a significant delay, a third poly¿a non¿vitamin e standard perform +0¿was opened and successfully implanted with an eccentric tray.Attempts to seat the original polys were made both in vivo and on the back table.The eccentric tray used for implantation had also failed to seat the original two polys.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event was not confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: a visual inspection of the returned poly insert shows no signs of wear and is in like new condition.The only exception is light deformation to the poly tabs on the underside of the reversed insert, which appears to have been caused by attempted insertion of the collar from the mating component.A functional test of the device using an r&d testing fixture confirms that it locks into place and operates as intended.A dimensional inspection of the device was performed by the original manufacturing vendor.The attached data sheet shows several measurements out of specification, which were determined to be the result of poly compression caused during the initial assembly attempt and subsequent functional testing.However, when compared to the original manufacturing records, the device was confirmed to have met specifications at the time of manufacture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that during surgery, two hrs -2 polyethylene inserts (polys) were unable to connect to the hrs centered tray.Both inserts were impacted but did not seat, resulting in their disposal.The centered tray was then removed from use, and a new centered tray was opened; however, both original polys again failed to seat.After a significant delay, a third poly¿a non¿vitamin e standard perform +0¿was opened and successfully implanted with an eccentric tray.Attempts to seat the original polys were made both in vivo and on the back table.The eccentric tray used for implantation had also failed to seat the original two polys.

• 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: 22794802
• Report Number: 0001649390-2025-00565
• Device Sequence Number: 15532411
• Product Code: KWS
• UDI-Device Identifier: 00846832094233
• UDI-Public: (01)00846832094233(1)240801(17)290801(21)AZ4322341014
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K241878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: AZ4322341014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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