MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED PROSTHESIS STEM; SHOULDER JOINT METAL/POLYMER PROSTHESIS

Model Number	DIA. 6.5 LG 100
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2016
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
It was reported that a patient underwent a revision surgery due to the dissociation in vivo between the metaphysis and the stem.
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED PROSTHESIS STEM
• Common Device Name: SHOULDER JOINT METAL/POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 6279538
• Report Number: 3000931034-2017-00047
• Device Sequence Number: 153592
• Product Code: KWS
• UDI-Device Identifier: 03700386916328
• UDI-Public: 03700386916328
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2016

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: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: DIA. 6.5 LG 100
• Device Catalogue Number: DWB941
• Device Lot Number: 4298AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 01/25/2018
• 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: Required Intervention
• Patient Age: 61 YR