MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ505
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, in (b)(6) 2024 the primary implantation of tornier flex components / perform reversed components was done.The indication for which the implant was initially used was not a fracture, degenerative arthrosis.On (b)(6) 2026, the revision surgery was done due to glenoid bone erosion.The implant was properly set, but the bone quality was really poor and the implant started loosening early with the bone integration.The revision surgery faced a huge bone loss surgical delay of 15 minutes to manage vein bleeding and vein bleeding was managed properly, no adverse consequences.Procedure was completed successfully.The final implant was a hemiarthroplasty with glenoid bone graft, instead of a re-implant with a reversed implant in the glenoid.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation, and no other evidence was provided.A device inspection was not possible since the affected device was not returned for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labelling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, in (b)(6) 2024 the primary implantation of tornier flex components / perform reversed components was done.The indication for which the implant was initially used was not a fracture, degenerative arthrosis.On (b)(6) 2026, the revision surgery was done due to glenoid bone erosion.The implant was properly set, but the bone quality was really poor and the implant started loosening early with the bone integration.The revision surgery faced a huge bone loss surgical delay of 15 minutes to manage vein bleeding and vein bleeding was managed properly, no adverse consequences.Procedure was completed successfully.The final implant was a hemiarthroplasty with glenoid bone graft, instead of a re-implant with a reversed implant in the glenoid.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 24763390
• Report Number: 0001649390-2026-00325
• Device Sequence Number: 13336939
• Product Code: PHX
• UDI-Device Identifier: 00846832090341
• UDI-Public: 00846832090341
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/30/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG