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

Model Number DIAMETER 42MM

Device Problem Device Issue (2379)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

Event 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.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED CEMENTED HUMERAL METAPHYSIS
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7116605
• MDR Text Key: 94800957
• Report Number: 3000931034-2017-00219
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386916335
• UDI-Public: 03700386916335
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other