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

Model Number ARS741803

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

Patient Problem Bone Fracture(s) (1870)

Event Date 10/04/2021

Event Type  Injury  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 285046352
• Report Number: 3004983210-2022-00011
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832069613
• UDI-Public: 00846832069613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 116 KG