MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOSPHERE CENTERED 36 MM X 25MM

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem Joint Laxity (4526)

Event Date 10/13/2021

Event Type  Injury  

Event Description

Revision surgery due to patient dislocating, a larger glenoid sphere was implanted.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition unknown.

Event Description

Revision surgery due to patient dislocating, a larger glenoid sphere was implanted.

Manufacturer Narrative

Corrections: refer to d2a common device name.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.Based on previous similar cases, the glenoid/humeral dislocation/instability problem is often due to the following reasons: previous surgery (previous osteosynthesis, hemiarthroplasty, total anatomic reversed prosthesis), delto-pectoral approach, obesity or bone conflict inducing a lever-out effect, soft-tissue deficiency (subscapularis, deltoid), shortened humerus due to proximal bone loss or improper restoration of the humeral length, excessive glenoid medialization due to glenoid bone defect, insufficient glenoid bone stock or poor bone quality leading to a weak anchorage of the glenoid implant, intraoperative inadequate choice of the components, improper positioning of the implant components, traumatic event, reeducation procedure not respected, or inadequate patient use in post-operative (surgeon advices not respected).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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 25MM
• Type of Device: 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: 12789750
• MDR Text Key: 282097258
• Report Number: 3000931034-2021-00338
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GLENOSPHERE CENTERED 36 MM X 25MM
• Device Catalogue Number: DWD180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention