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

Model Number	42MM 10° TILTED FOR 29MM
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the nitial report submitted regarding this surgical event and medical device.The second glenoid sphere information is as follows: batch no 1721au027.Manufacturing date: 22-jan-2019 / expiration date: 17-jan-2024.
Event or Problem Description
The 42 x 29mm tilted glenoid sphere's center pin did not want to loosen up.Myself as rep tried and when the screw driver slipped i changed the screw driver tip to a new one.The surgeon also tried to loosen the pin after me but failed to do so too.Upon instruction we opened a second 42 x 29mm tilted glenoid sphere and the same thing happened.The pin was stuck and we could not turn the center pin clockwise or anti-clockwise.The surgery was completed by using a third implant, a 42 x 29mm eccentric glenoid sphere.This resulted in the patient's operating time increasing with at least 30 minutes.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED II GLENOID SPHERE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8598900
• Report Number: 3000931034-2019-00075
• Device Sequence Number: 11333013
• Product Code: KWS
• UDI-Device Identifier: 03700386935923
• UDI-Public: 03700386935923
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 01/22/2024
• Device Model Number: 42MM 10° TILTED FOR 29MM
• Device Catalogue Number: DWD194
• Device Lot Number: 1725AU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR