MAUDE Adverse Event Report: TORNIER INC PERFORM 55% INSERT VE SZ1/2 36 MM +3; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWS3363
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Believed the polyethylene component was properly seated intraoperatively.Postoperatively, the polyethylene was found to have disengaged, indicating a potential issue with component engagement or assembly.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that both the surgeon and sales rep believed the polyethylene component was properly seated intraoperatively.Postoperatively, the polyethylene was found to have disengaged.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection of the returned device revealed chipping of the polymer material at multiple locations, along with deep scratch marks, possibly incurred during use.Furthermore, functional testing of the returned polyethylene insert was performed using a test jig.The device seated properly on the jig when impacted, indicating normal functionality.As a result, the reported issue could not be confirmed.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.Based on the investigation findings, the reported issue could not be confirmed, therefore root cause could not established.If more information is provided, the case will be reassessed.

• Brand Name: PERFORM 55% INSERT VE SZ1/2 36 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): 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 ; 2018315000
• MDR Report Key: 24071080
• Report Number: 0001649390-2026-00045
• Device Sequence Number: 13044006
• Product Code: PAO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: DWS3363
• Device Lot Number: AJ7787
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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 Sex: Unknown