MAUDE Adverse Event Report:; ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 10X108MM

; ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 10X108MM

Catalog Number 530-10-108

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Fracture, Arm (2351)

Event Type Injury

Manufacturer Narrative

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

Event Description

Revision surgery - due to the fractured humerus causing the implant to loosen.The surgeon replaced it with a monoblock.

1 Device was Involved in the Event
Type of Device	ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 10X108MM
MDR Report Key	10686970
MDR Text Key	211642516
Report Number	1644408-2016-00473
Device Sequence Number	1
Product Code	PHX
Combination Product (y/n)	N
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Manufacturer
Type of Report	Initial
Report Date	10/08/2020
1 Patient was Involved in the Event
Is this an Adverse Event Report?	Yes
Is this a Product Problem Report?	No
Device Operator	No Information
Device Catalogue Number	530-10-108
Device Lot Number	409T1051
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	10/15/2020
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Other; Required Intervention;