MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 36MM DIA +6 45%; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1366
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
A revision surgery due to shoulder dislocation and related pain occurred.It was reported that: "during the revision surgery, the surgeon realized that the 45 percent of the mismatch couverture was insufficient.".
Event or Problem Description
A revision surgery due to shoulder dislocation and related pain occurred.It was reported that: "during the revision surgery, the surgeon realized that the 45 percent of the mismatch couverture was insufficient.".
Additional Manufacturer Narrative
Corrected field: reporting contact (g1).The reported event could not be confirmed.The device was not returned for evaluation, but x-rays were provided for review.However, provided evidences did not conclusively confirm the event description.A device inspection was not possible since the affected device was not returned for investigation.Since x-rays were provided, the opinion of a medical expert was sought and stated as follows: all implant components are intact and look well placed in a good position.No dislocation is visible on the early postoperative x-ray.There is no information however on the soft tissue tension.The fact that the surgeon has used a spacer to increase soft tissue tension supports the suspicion of insufficient soft tissue tension.Insufficient soft tissue tension can be a factor in the instability.Failure of total shoulder replacement over time is a known complication.In case of a revision procedure a medical opinion aiming to determine the root cause of the failure is part of the internal investigation process.Sufficient (radiological and clinical) information must be provided to enable a meaningful clinical assessment and to identify possible causes of failure.In cases where no such information is available, this assessment is limited.No conclusive statement can be provided, because key clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient, assessment of the treating physician) is missing.Due to these limitations, i am unable to provide statements about the patient, the procedure, and/or the device in relation to cause of the failure.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.The event was the most likely caused by an insufficient soft tissue tension, but more detailed information about the complaint event must be available in order to determine a clear root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM REV INSERT SZ 1/2 36MM DIA +6 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: 21576551
• Report Number: 0001649390-2025-00139
• Device Sequence Number: 15688384
• Product Code: PHX
• UDI-Device Identifier: 00846832084418
• UDI-Public: (01)00846832084418(11)221229(17)271229(21)3576AY034
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWP1366
• Device Lot Number: 3576AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2022
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female