MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 36MM DIA +0 45%; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1360
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Subluxation (4525); Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "subject: 09-013 phs stemless ide study.Post-operative complication: instability - subluxation.Endorses subluxation/dislocation event while cutting frozen cheese.Able to self-reduce.Pain dissipated with reduction.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the medical expert opinion on the available x-ray record.A review of the x-rays by the medical expert stated.¿the device was used as intended.There is no evidence of poor bone quality.The humeral implant and reverse tray losing centered contact with the glenosphere.¿ 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 and formal medical expert opinion, the root cause is attribute most likely to a patient related factor.Most probably insufficient soft tissue tension or trauma or overexertion may also play a role.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "subject: (b)(6) phs stemless ide study.Post-operative complication: instability - subluxation.Endorses subluxation/dislocation event while cutting frozen cheese.Able to self-reduce.Pain dissipated with reduction.".

• Brand Name: PERFORM REV INSERT SZ 1/2 36MM DIA +0 45%
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21574038
• Report Number: 0001649390-2025-00136
• Device Sequence Number: 12848912
• Product Code: PHX
• UDI-Device Identifier: 00846832084395
• UDI-Public: 00846832084395
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: DWP1360
• Device Lot Number: AF4134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2022
• 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: Other
• Patient Age: 56 YR
• Patient Sex: Female