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

Model Number	DIAMETER 42MM
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2017
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 purpose of the surgery was to assemble a humeral head to a reversed metaphysis.Screwing of the union screw with the metaphysis ok, assembly of the adaptor, and in spite a good impaction, the adaptor does not hold, and while impacting, the humeral head lifts.The rotational motion is not blocked properly on the humeral head.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED CEMENTED HUMERAL METAPHYSIS
• 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: 7116605
• Report Number: 3000931034-2017-00219
• Device Sequence Number: 11246338
• Product Code: KWS
• UDI-Device Identifier: 03700386916335
• UDI-Public: 03700386916335
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030941
• 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): 11/17/2017

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: 05/29/2022
• Device Model Number: DIAMETER 42MM
• Device Catalogue Number: DWB961
• Device Lot Number: AB0652
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/17/2019
• 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