MAUDE Adverse Event Report: TORNIER INC. AEQUALIS REVERSED CUSTOM; SHOULDER JOINT METAL/METAL CUSTOM PROSTHESIS

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.Literature source: early outcomes following metal-on-metal reverse total shoulder arthroplasty in patients younger than 50 years.Clay riley, md; john idoine, do; yousef shishani, md; reuben gobezie, md; bradley edward s, md.Orthopedics.2016 jun 23:1-5.Http://www.Ncbi.Nlm.Nih.Gov/pubmed/27337662.

Event Description

Literature indicated: "infection 2 mo later, multiple i&d with prosthetic retention" no further patient complications or surgical details have been reported in relation to this event.

• Brand Name: AEQUALIS REVERSED CUSTOM
• Type of Device: SHOULDER JOINT METAL/METAL CUSTOM PROSTHESIS
• Manufacturer (Section D): TORNIER INC.; 10801 nesbit avenue south; bloomington MN 55437
• Manufacturer Contact: dustin smith ; 10801 nesbit ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 5865482
• MDR Text Key: 51748861
• Report Number: 3004983210-2016-00029
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• 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: 27 YR