MAUDE Adverse Event Report: TORNIER S.A.S. PM PRIMARY REVERSED BASEPLATE 25MM POST, CENTERED, 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
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
The primary reverse procedure employed tornier implants, including the shoulder id baseplate and perform humeral.The observed baseplate failure is attributed to likely over-lateralization, stemming from the thickness of the shoulder id baseplate and a lateralized glenosphere.
Additional Manufacturer Narrative
Corrections: the fda registration number was 0001649390 - te (blooming) but should have been 3000931034 - te mtbonnot.D3 legal manufacturer.G1 manufacturing site.
Event or Problem Description
The primary reverse procedure employed tornier implants, including the shoulder id baseplate and perform humeral.The observed baseplate failure is attributed to likely over-lateralization, stemming from the thickness of the shoulder id baseplate and a lateralized glenosphere.

• Brand Name: PM PRIMARY REVERSED BASEPLATE 25MM POST, CENTERED, 25MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19328768
• Report Number: 0001649390-2024-00236
• Device Sequence Number: 7009653
• Product Code: PHX
• UDI-Device Identifier: 00840338604286
• UDI-Public: 00840338604286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: DWJ603
• Device Lot Number: 07TL05S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Male