MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV TRAY 12TH 3.5MM OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF522
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that there was luxation of the implant after rehabilitation and the patient underwent a revision surgery.
Event or Problem Description
It was reported that there was luxation of the implant after rehabilitation and the patient underwent a revision surgery.
Additional Manufacturer Narrative
Please note the correction to the d4 lot#: the reported event could be confirmed since an x-ray was provided and matches the alleged failure mode.Indeed, since a post-operative x-ray was provided, the opinion of the medical expert was requested and stated: "without further x-rays and clinical and technical information, it is difficult to make a detailed assessment.The provided x-ray shows indeed a disassembly / dissociation between the aequalis ascend flex stem and the reversed tray [tray completely out of the stem].Therefore, the normal alignment between the humerus and the glenoid is lost (joint dislocation).The reversed tray is 12 mm thick, which is exceptional.I cannot determine the root cause on the information available at this time".The devices inspection revealed the following: -visually, some damage portions and scratches were observed at the flat surface level of the stem, and deep scratches were observed at the taper level of the tray (damages probably due to frictions of the tray on the stem, performed when the tray disassembled and migrated out of the stem in-vivo).-dimensionally, all devices met the specifications at the functional tray/stem portion.-functionally, a tray/stem assembly was carried out and showed that the two devices could assembled with no issue to report.But due to the nature of the returned devices, it is not possible to guarantee the impaction at 100% reliable.Unfortunately, no immediate post-operative surgery x-rays were provided for investigation to check if the tray was indeed correctly seated into the stem immediately after surgery.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.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.As a reminder, the labeling documents state that: "the surgeon should inspect the implant tapers and mating surfaces for debris or blemishes before assembly.The tapers should be clean and dry for assembly".Moreover, "the following situations threaten the success of the shoulder replacement implant: - sport activity or high activity level (.)" and "the fact that active motion in the arm is restricted in daily activity as only elbow, wrist and finger motion is allowed during the rehabilitation (.)".No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS REV TRAY 12TH 3.5MM OFFSET
• 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): 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: 15749186
• Report Number: 3000931034-2022-00364
• Device Sequence Number: 15008981
• Product Code: KWS
• UDI-Device Identifier: 03700434019322
• UDI-Public: 03700434019322
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 04/09/2023
• Device Model Number: DWF522
• Device Catalogue Number: DWF522
• Device Lot Number: 5960AT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2018
• 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: Male