MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTED METAPHYSIS; SHOULDER JOINT CEMENTED PROSTHESIS

Model Number	DIA. 36
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/29/2016
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
Patient originally received an aequalis reversed shoulder on (b)(6) 2009.Patient recently presented with shoulder pain and loss of mobility.Upon x-ray examination on (b)(6) 2016, it was revealed that the metaphysis had completely dissociated from the humeral stem.Failed device was removed from patient on (b)(6) 2016.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED CEMENTED METAPHYSIS
• Common Device Name: SHOULDER JOINT CEMENTED PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5982943
• Report Number: 3000931034-2016-00151
• Device Sequence Number: 958319
• Product Code: KWS
• UDI-Device Identifier: 03700386916328
• UDI-Public: 03700386916328
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/31/2014
• Device Model Number: DIA. 36
• Device Catalogue Number: DWB960
• Device Lot Number: 1441AI019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 12/05/2017
• 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