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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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
• 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: 11876630
• Report Number: 3000931034-2021-00255
• Device Sequence Number: 11037661
• Product Code: KWS
• UDI-Device Identifier: 03700386916175
• UDI-Public: 03700386916175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• 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
• Patient Age: 66 YR