MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN FLEX INSERT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF365B
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Dislocation (2374)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not available.
Event or Problem Description
It was reported that the "reduction of the inverted prosthesis dislocation by external maneuver without any difficulty.Clinical control of mobility.Scopic control of the reduction." the patient underwent a surgery to remove the implants.
Additional Manufacturer Narrative
The reported event could not be confirmed since the devices were not returned for evaluation and no other visible evidences, from the x-rays provided for investigation, could confirm the shoulder dislocation.A device inspection was not possible since the affected devices were not returned.Since data were provided, the opinion of a medical expert was sought and stated as following: "the case describes instability of the index-implant with wear of the anterior and posterior sides of the pe-inlay, that was according to the intraoperative report, rotated 180 degrees.The surgeon suggested a relationship with parkinson¿s disease.The issue was resolved by exchange of the inlay/tray and glenosphere, in order to provide more soft tissue tension.In conclusion, with the information applicable, it seems plausible that this event is a patient related issue (¿) the failure mode could not be confirmed from the x-rays that are available.There are no clear signs of inlay rotation in the x-rays.This can only be assessed indirectly, since polyethylene is not visible on x-rays most of the time.No x-rays were taken when the dislocation was present¿.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 (as patient conditions, devices, pre-revision x-rays/images, batch numbers of the implants.) about the complaint event must be available in order to determine the exact root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the "reduction of the inverted prosthesis dislocation by external maneuver without any difficulty.Clinical control of mobility.Scopic control of the reduction." the patient underwent a surgery to remove the implants.

• Brand Name: UNKNOWN FLEX INSERT
• 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: 17172574
• Report Number: 3000931034-2023-00178
• Device Sequence Number: 17900491
• Product Code: KWS
• UDI-Device Identifier: 03700434022582
• UDI-Public: 03700434022582
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DWF365B
• Device Catalogue Number: DWF365B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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: 82 YR
• Patient Sex: Male