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

Model Number	CEMENTED STEM 6.5MM X 100MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/05/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
This is an aequalis reverse post approval study report.On (b)(6) 2014: a crack occurred during the proximal humerus treatment during the aequalis reverse surgery.The entire area around the fissure was secured with strong suture thread and the surgery was completed.

• Brand Name: AEQUALIS REVERSED CEMENTED STEM 6.5MM X 100MM
• Common Device Name: PROSTHESIS SHOULDER JOINT METAL
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 12046366
• Report Number: 3000931034-2021-00288
• Device Sequence Number: 4259572
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: Health Professional
• Device Expiration Date: 09/02/2019
• Device Model Number: CEMENTED STEM 6.5MM X 100MM
• Device Catalogue Number: DWB940
• Device Lot Number: 9072AO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/22/2021
• 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: 75 YR