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

Model Number	DIAM 6,5MM ; L100MM CEMENTED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
"this patient had an initial surgery of ascend flex rsa on (b)(6) 2014.The implants used in this surgery were (dwb940), (dwb960), (dwb993), (dwd180), (dwd170), (vdv118), (vdv126), (dwd120)×2.And after four years and seven months, when the patient had an x-ray on (b)(6) 2019, fracture of the humeral bone fracture was found.Revision surgery performed on (b)(6) 2019.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED HUMERAL STEM
• 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: 8800570
• Report Number: 3000931034-2019-00110
• Device Sequence Number: 16221177
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 09/30/2019
• Device Model Number: DIAM 6,5MM ; L100MM CEMENTED
• Device Catalogue Number: DWB940
• Device Lot Number: 9072AO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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: 79 YR