MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 39MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ023
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/02/2023
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
It was reported that the patient required revision surgery after experiencing loosening of the glenosphere.The glenosphere was replaced successfully and with good outcome for the patient.
Additional Manufacturer Narrative
Please note correction to h6 (device code and clinical signs code).The reported event could not be confirmed the since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the visual inspection the returned device reveals excessive usage.The surface of the glenosphere has several and significant scratches and gouge marks at the set screw level.The star footprint is slightly deformed at the safety screw input.Furthermore, a functional test of the returned device was performed with a sample baseplate and a screwdriver.The components assembled as intended without capture screw being frozen and allowing sufficient movement of the screw in the glenosphere.Therefore, alleged failure of loosening 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the reported issue could not be confirmed.If any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient required revision surgery after experiencing loosening of the glenosphere.The glenosphere was replaced successfully and with good outcome for the patient.

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 39MM
• 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: 18783688
• Report Number: 0001649390-2024-00067
• Device Sequence Number: 4289366
• Product Code: PHX
• UDI-Device Identifier: 00846832090389
• UDI-Public: 00846832090389
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024
• 2 Devices were Involved in the Event: 1 2

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: DWJ023
• Device Lot Number: CZ1421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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 Sex: Female