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

Model Number	SIZE XL
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/23/2018
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
"it was reported that a patient underwent a revision surgery due to implant breakage (glenoid insert) 11 years post-operative.Patient id: (b)(6).".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported that a patient underwent a revision surgery due to implant breakage (the glenoid component was fragmented and worn) 11 years post-operative.Patient id : (b)(6).

• Brand Name: AEQUALIS GLENOID BASE 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: 7308955
• Report Number: 3000931034-2018-00021
• Device Sequence Number: 2273465
• Product Code: KWS
• UDI-Device Identifier: 03700386915444
• UDI-Public: 03700386915444
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K994393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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 Model Number: SIZE XL
• Device Catalogue Number: DWB213
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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: 72 YR
• Patient Weight: 68