MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD191
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526); Implant Pain (4561)
Date of Event	11/17/2021
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.
Event or Problem Description
It was reported that the patient underwent a revision due to dislocation after a fall; it was not related to any device.There was also loosening of the prosthesis, rotator cuff insufficiency , poly wear, and the patient had pain.Insert was replaced to 42+9a; the tray was replaced to a high+0.
Event or Problem Description
It was reported that the patient underwent a revision due to dislocation after a fall; it was not related to any device.There was also loosening of the prosthesis, rotator cuff insufficiency , poly wear, and the patient had pain.Insert was replaced to 42+9a; the tray was replaced to a high+0.
Additional Manufacturer Narrative
Despite the device was not returned, the x-rays provided confirm the dislocation of the device.This conclusion was verified by a medical expert upon review of the patient's case documentation.The opinion of the medical expert state as following: "please note that, the x-ray shows some scapular bone loss because of notching which may lead to accelerated wear and/or deformation of the polyethylene inlay.That in turn will lead to loss of conformity and a higher change of dislocation during a fall." [¿] "evidently the implant wasn¿t loose as in loss of osteointegration, but i must suspect loose as in lack of stability due to the soft tissue laxity.Only replacing the modular components confirm that.Loss of osteointegration with loosening of either the glenoid baseplate or the humeral stem would have led to a total system revision." [¿] "it is not possible to make statements on the rotator cuff, since it is not known how this was pre-dislocation.In many rtsa cases the rotator cuff is irreparably damaged, making rtsa the implant of choice." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 29MM
• 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: 13861952
• Report Number: 3000931034-2022-00149
• Device Sequence Number: 14625534
• Product Code: KWS
• UDI-Device Identifier: 03700386935893
• UDI-Public: 03700386935893
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: DWD191
• Device Catalogue Number: DWD191
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/28/2022
• 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 Sex: Unknown