MAUDE Adverse Event Report: TORNIER S.A.S AEQUALIS REVERSED II; PROSTHESIS SHOULDER METAL

Model Number GLENOID SPHERE Ø36/Ø29/CENTERED

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Failure of Implant (1924)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.Based on the x-rays available, no issue can be reported.The glenoid sphere seems being well impacted.The problem is probably linked with engagement issue of the screw into the baseplate before disengaging from the glenosphere.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.

Event Description

The screw would not engage the baseplate (when he went to screw, after impacting).The center screw kept spinning.The glenoid spere was left in patient.Dr.Felt the sphere was still attached to the baseplate in a sound & secure fashion.

• Brand Name: AEQUALIS REVERSED II
• Type of Device: PROSTHESIS SHOULDER METAL
• Manufacturer (Section D): TORNIER S.A.S; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin 38330 ; FR 38330
• MDR Report Key: 13606746
• MDR Text Key: 289522050
• Report Number: 3000931034-2022-00063
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935886
• UDI-Public: 03700386935886
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2021
• Device Model Number: GLENOID SPHERE Ø36/Ø29/CENTERED
• Device Catalogue Number: DWD190
• Device Lot Number: AA3780
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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): Other