MAUDE Adverse Event Report:; HEAD, HUMERAL, OFFSET, 46-20

Catalog Number 520-46-120

Device Problem Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - due to post operation rotator cuff deficiency of the right shoulder.The surgeon performed a revision, of an arthroplasty to a reverse shoulder.

• Type of Device: HEAD, HUMERAL, OFFSET, 46-20
• MDR Report Key: 11816681
• MDR Text Key: 250361966
• Report Number: 1644408-2017-00324
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 520-46-120
• Device Lot Number: 925C1082
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention