MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4 39MM DIA +0 10 DG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWR2390
Medical Device Problem Codes	Positioning Failure (1158); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was confirmed, bases on the evaluation done by hcp on provided x-ray images.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, design & manufacturing related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.However, on the available x-rays medical opinion was sought from an experienced independent medical expert as below, ¿the image shows that the metal ring is projected outside the humeral tray and there is a clear confirmation of polyethylene insert dislocation from the humeral tray.All other implant components are intact and in a good position.Because of the polyethylene insert dislocation the shoulder is subluxated¿.Based on investigation, definitive root cause could not be determined with the available x-ray image.The most probable causes are improper intraoperative assembly of the polyethylene insert in the humeral tray because of improper alignment during impaction, interposition of fluid or tissue or parts of surgical gauze.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient had to undergo a revision surgery the same day as the initial surgery due to the poly not seating correctly and dislocating in the recovery room post-op.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient had to undergo a revision surgery the same day as the initial surgery due to the poly not seating correctly and dislocating in the recovery room post-op.

• Brand Name: PERFORM REV INSERT SZ 3/4 39MM DIA +0 10 DG
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19578286
• Report Number: 0001649390-2024-00273
• Device Sequence Number: 3980316
• Product Code: PHX
• UDI-Device Identifier: 00846832084845
• UDI-Public: 00846832084845
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: DWR2390
• Device Lot Number: AF4884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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 Sex: Unknown