MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 42MM 6TH B 12.5DEG; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	DWF421B
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a first revision surgery due to instability/dislocation on (b)(6) 2017.The associated adverse event dated (b)(6) 2017 describes a dislocated reverse with a definite relatedness to the surgical procedure and no relatedness to the study device.
Additional Manufacturer Narrative
The device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 42MM 6TH B 12.5DEG
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12867145
• Report Number: 3000931034-2021-00350
• Device Sequence Number: 17009072
• Product Code: KWS
• UDI-Device Identifier: 03700386940866
• UDI-Public: 03700386940866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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 Model Number: DWF421B
• Device Catalogue Number: DWF421B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/24/2021
• 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: 64
• Patient Sex: Male
• Patient Weight: 215 KG