MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE DISTAL STEM 13DIA; HEMI HUMERAL METALLIC UNCEMENTED PROSTHESIS SHOULDER

Model Number	ARS741803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Ae # 1 : (b)(6) 2021 - post operative complication : intraoperative gt insufficiency fracture.Noticed as not related to the device.Possible relatedness to the surgical procedure.Action taken : suture cerclage (primary study surgery done (b)(6) 2021 - other company implants removed and aeq flex revive stem implanted (reversed configuration + perform + implants).
Additional Manufacturer Narrative
The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.

• Brand Name: AEQUALIS FLEX REVIVE DISTAL STEM 13DIA
• Common Device Name: HEMI HUMERAL METALLIC UNCEMENTED PROSTHESIS SHOULDER
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 13440013
• Report Number: 3004983210-2022-00011
• Device Sequence Number: 2160338
• Product Code: HSD
• UDI-Device Identifier: 00846832069613
• UDI-Public: 00846832069613
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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 Model Number: ARS741803
• Device Catalogue Number: ARS741803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 116 KG