MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH C 7.5DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF364C
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery to seat the interface between the tray and poly properly.During initial surgery, the interface between the tray and the poly did not seat even after repeating impaction.Although, the interface appeared seated on x-ray, the snap ring did not engage.The poly was disassociated with the tray within 24 hours of the case.
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.
Additional Manufacturer Narrative
Correction: please refer to d6a implant date.The reported event could be confirmed for the dissociated poly insert with the tray in post-operative but could not be confirmed with the returned device since it is conforming to specifications and fully functional.The received insert showed vertical marks-ribs all along the groove edges (due to the tray teeth when inserting the insert into the tray), which deformed slightly the insert at the groove level and punched the circlip.A functional insertion test carried out with a reversed tray available from our premises showed that the insert could correctly seat into the tray with no issue to report (no gap or insert/tray micro-motion were observed).Moreover, after being impacted, the insert was difficult to extract with an insert revision clamp.The device was still functional.The issue described in the complaint was unable to reproduce.Dimensionally, all dimensions were conforming to specifications.The residual gap between the insert and the tray remained in the acceptable tolerances.Since a postoperative x-ray taken the day after the surgery was provided, the opinion of the medical expert was requested and stated: "neither the x-ray nor the data on the dimensions of the device show any abnormalities, besides the dislocation of the pe-liner on the postoperative x-ray" (metal ring out of the tray).Unfortunately, no immediate post-operative surgery x-rays were provided for investigation to check if the insert was indeed correctly seated into the tray immediately after surgery.More detailed information about the complaint event must be available to determine the root cause of the complaint event.In this case, it is unlikely that the device found fully functional could have caused the reported event.As a reminder, the operation technique states 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" and that "the groove marking on the insert impactor tip must be aligned with the laser mark of the insert (12 o´clock position of the humerus)".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
It was reported that a patient underwent a revision surgery to seat the interface between the tray and poly properly.During initial surgery, the interface between the tray and the poly did not seat even after repeating impaction.Although, the interface appeared seated on x-ray, the snap ring did not engage.The poly was disassociated with the tray within 24 hours of the case.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH C 7.5DEG
• 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): 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: 15188489
• Report Number: 3000931034-2022-00271
• Device Sequence Number: 17754222
• Product Code: KWS
• UDI-Device Identifier: 03700434022209
• UDI-Public: 03700434022209
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: DWF364C
• Device Catalogue Number: DWF364C
• Device Lot Number: 6462AX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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: 66 YR
• Patient Sex: Female