MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 42MM 6TH C 7.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF421C
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient had dislocated their shoulder and so a revision surgery was planned.Surgeon removed the tray and poly and a new tray was put in and an upsized poly.Left side.No adverse consequences during the revision surgery.The patient was aware that they had dislocated their shoulder and as such needed it to be revised.The incident was not in relation to any malfunction of the implants/devices.It was revised due to patient dislocating and need a larger sized implant.In the image the implant looks broken that is only because it was damaged by the surgeon during removal of the implant.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "patient had dislocated their shoulder and so a revision surgery was planned.Surgeon removed the tray and poly and a new tray was put in and an upsized poly.Left side.No adverse consequences during the revision surgery.The patient was aware that they had dislocated their shoulder and as such needed it to be revised.The incident was not in relation to any malfunction of the implants/devices.It was revised due to patient dislocating and need a larger sized implant.In the image the implant looks broken that is only because it was damaged by the surgeon during removal of the implant.".
Additional Manufacturer Narrative
The reported event could not be confirmed as no evidence other than the returned device was provided.The devices inspection revealed the following: the plastic insert is extremely deformed and cracked, and the tray is well scratched and deformed, probably due to implants removal.Due to the nature of the returned devices, a functional and dimensional inspection was not possible.The opinion of the medical expert was requested on this case despite the limited information provided, and stated as following: "most likely the instability was related to insufficient soft tissue tension, hence the revision with the implantation of a thicker polyethylene insert.The marks on the explanted implant look typical for being caused by several attempts to extract the pe insert from the tray.There are no x-rays available showing implant positioning, therefore that cannot be assessed".A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event (x-rays, surgical reports ¿), must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 42MM 6TH C 7.5DG
• 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: 18263495
• Report Number: 3000931034-2023-00447
• Device Sequence Number: 19822360
• Product Code: KWS
• UDI-Device Identifier: 03700434021561
• UDI-Public: 03700434021561
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Catalogue Number: DWF421C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Male