MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH B 12.5DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF364B
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	12/24/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to instability/dislocation of the implant.Primary surgery was conducted 3 days post-op the patient had instability/dislocation of the implant (x-ray control: ptei cat dislocation.Reduction / immobilization by abduction cushion on the same day) 4 months later there was recurrence of prosthetic dislocation: repeat with glenosphere.Patient underwent a revision surgery 4 days later with revision of the insert and glenosphere.Resolved with sequelae (x-ray 5 years after revision).
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 was revised due to instability/dislocation of the implant.Primary surgery was conducted.3 days post-op the patient had instability/dislocation of the implant (x-ray control: ptei cat dislocation.Reduction / immobilization by abduction cushion on the same day) 4 months later there was recurrence of prosthetic dislocation: repeat with glenosphere.Patient underwent a revision surgery 4 days later with revision of the insert and glenosphere.Resolved with sequelae (x-ray 5 years after revision).
Additional Manufacturer Narrative
Correction: h6 device code and clinical code.The reported event could be confirmed.The devices were not returned but evidences were provided, based on provided x-rays, which matches the alleged failure.X-rays inspection showed twice a glenoid/humeral dislocation of the shoulder.Since x-rays were provided, the opinion of a medical expert was sought and stated as following: "most likely the dislocation is multifactorial.One of the factors probably was the lack of soft tissue tension, hence the surgeon has changed the articular components (glenosphere and polyethylene liner) to increase that.Other reasons are more difficult to assess from the information available".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.More detailed information about the complaint event (as patient conditions and surgery information) as well as the affected devices must be available in order to determine an exact root cause of the complaint event.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH B 12.5DEG
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16603915
• Report Number: 3000931034-2023-00075
• Device Sequence Number: 5996045
• Product Code: KWS
• UDI-Device Identifier: 03700434022612
• UDI-Public: 03700434022612
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/04/2020
• Device Model Number: DWF364B
• Device Catalogue Number: DWF364B
• Device Lot Number: AA0579058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 72 KG