MAUDE Adverse Event Report: TORNIER INC PERFORM 55% INSERT SZ3/4 39 MM +6; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP4396
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon 2-week post-op visit, perform humeral poly was found to be disassociated from the perform humeral stem.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Upon 2-week post-op visit, perform humeral poly was found to be disassociated from the perform humeral stem.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: visual inspection: a visual inspection was performed on returned device and revealed, the plastic component of the insert is damaged from one of the corners near the metallic ring.Few scratch marks are also visible on the curvature of the insert.Additionally, a medical opinion was asked and noted under additional document review section.Moreover, functional testing of the returned device showed that poly seated properly on the test jig after three impacts and remained secure, even when attempts were made to pull it off.Therefore, 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 investigation, the root cause was attributed to a user related issue.Most likely, the event was caused due to improper seating achieve by surgeon while implanting.If more information is provided, the case will be reassessed.

• Brand Name: PERFORM 55% INSERT SZ3/4 39 MM +6
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 23994564
• Report Number: 0001649390-2026-00022
• Device Sequence Number: 10240246
• Product Code: PHX
• UDI-Device Identifier: 00846832084685
• UDI-Public: (01)00846832084685(11)261006(17)301006(21)AJ8748010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: DWP4396
• Device Lot Number: AJ8748010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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 Age: 69 YR
• Patient Sex: Male