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

Model Number	GLENOID SPHERE Ø36/Ø29/CENTERED
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/09/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3000931034-2022-00063
• Device Sequence Number: 1969589
• Product Code: KWS
• UDI-Device Identifier: 03700386935886
• UDI-Public: 03700386935886
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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: Other
• Patient Sex: Unknown