MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PERFORM GLENOID; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	SIZE L60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
The surgeon prepared the glenoid for an l60 cortiloc glenoid and the trial seated flush with the bone.When he went to seat the final implant, it would not sit flush with the bone.He tried to get it seated without success and ultimately decided to pull it out and it came out fairly easily.Upon inspection, the surgeon observed the inferior-posterior peg was bent and concluded this was the issue.The surgeon removed the cement and re-prepped the glenoid for an l50 which added 20 minutes approximately to the surgery.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS PERFORM GLENOID
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7193172
• Report Number: 3000931034-2018-00001
• Device Sequence Number: 19298712
• Product Code: KWS
• UDI-Device Identifier: 03700386937538
• UDI-Public: 03700386937538
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: Physician
• Device Expiration Date: 02/15/2022
• Device Model Number: SIZE L60
• Device Catalogue Number: DWE423
• Device Lot Number: AA9112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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: 63 YR