MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE DISTAL STEM 19DIA; HEMI HUMERAL UNCEMENTED SHOULDER PROSTHESIS

Catalog Number ARS741806

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

Patient Problem Bone Fracture(s) (1870)

Event Date 10/18/2021

Event Type  Injury  

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.

Event Description

It was reported that patient (b)(6) had a periprosthetic fracture on (b)(6) 2021.(while removing competitor prosthetic components (stem, humeral head and glenoid component implanted in 2013) and placing aequalis flex revive stem, tray and insert with perform reversed baseplate and glenosphere.) imaging shows a minimally displaced periprosthetic fracture distal to the stem on the posterior side.Prior surgeries on study shoulder: total shoulder arthroplasty in 2013 and tsa revision in 2013.

• Brand Name: AEQUALIS FLEX REVIVE DISTAL STEM 19DIA
• Type of Device: HEMI HUMERAL UNCEMENTED SHOULDER PROSTHESIS
• 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: 13204847
• MDR Text Key: 283490010
• Report Number: 3004983210-2022-00005
• Device Sequence Number: 1
• Product Code: HSD
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ARS741806
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 95 KG