MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTED STEM 6.5MM X 100MM; SHOULDER JOINT METAL PROSTHESIS

Model Number CEMENTED DIAMETER 6.5MM LENGTH 100MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

This is an aequalis reverse post approval study report 9-02.After the patient had an initial surgery of aequalis reverse on (b)(6) 2014, a numbness in the hands was confirmed on (b)(6) 2014, but a wait-and-see approach was taken.Since it didn't seem to have any functional impact, so the surgeon decided to observe the situation as it was.

• Brand Name: AEQUALIS REVERSED CEMENTED STEM 6.5MM X 100MM
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 11876630
• MDR Text Key: 252443466
• Report Number: 3000931034-2021-00255
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386916175
• UDI-Public: 03700386916175
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: CEMENTED DIAMETER 6.5MM LENGTH 100MM
• Device Catalogue Number: DWB940
• Device Lot Number: 7569AN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2014
• 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: 66 YR