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

Model Number	DWJ603
Medical Device Problem Codes	Break (1069); Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Revision need to removed failed implant and convert to hemi-arthroplasty.
Additional Manufacturer Narrative
Please note the correction regarding b1 adverse event/product problem and h6 (device & clinical code): the reported event was confirmed since the device was returned for evaluation and other evidences were provided.On the device in return, we can observe some areas of osseointegration on the porous coating part of the baseplate.We can also observe some small scratches on the morse taper of the baseplate, these small defects probably appeared following the assembly and disassembly of the sphere during the interventions.No defect that would explain the cause of the loosening is observed.A functional inspection was performed with the bone model, the perform patient-matched reversed baseplate is correctly seated onto the bone model.Due to the nature of the complaint, a dimensional inspection was not considered necessary.Based on details available an exact root cause could not be confirmed but it could not be excluded that the reported event is rather related to the patient [poor quality and insufficient quantity of glenoid bone stock], which is confirmed by event description ¿¿patient's glenoid was worn more than computed via the ct due to the extent of time between scan to surgery.¿ 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.If more information is provided, the case will be reassessed.
Event or Problem Description
Revision need to removed failed implant and convert to hemi-arthroplasty.

• 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 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16268918
• Report Number: 3000931034-2023-00038
• Device Sequence Number: 20463662
• Product Code: PHX
• UDI-Device Identifier: 00846832079483
• UDI-Public: 00846832079483
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K211359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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 Expiration Date: 05/16/2023
• Device Model Number: DWJ603
• Device Catalogue Number: DWJ603
• Device Lot Number: 2UEL01T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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