MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS

Model Number 41X15 MM ECC 3.5 COCR

Device Problems Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Muscle Weakness (1967); Reaction (2414)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent a revision surgery 4 years post-operative due to an allergy to nickel combined with glenoid loosening and cuff failure.Patient id: (b)(6).

• Brand Name: AEQUALIS ASCEND FLEX HUMERAL HEAD
• 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: 8137240
• MDR Text Key: 129454162
• Report Number: 3000931034-2018-00185
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386940156
• UDI-Public: 03700386940156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2018

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
• Device Operator: No Information
• Device Expiration Date: 03/31/2019
• Device Model Number: 41X15 MM ECC 3.5 COCR
• Device Catalogue Number: DWF141
• Device Lot Number: 0250AO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• 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
• Patient Age: 47 YR
• Patient Weight: 57