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Health Sciences Authority
Dear Healthcare Professional Letters

Advice on the use of the optional Apex Hole Eliminator with certain PINNACLE® CUP devices which may have oversized “minor diameter”

Audiences

Healthcare professional

Industry member

Product type

Medical devices

1 March 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson Pte Ltd to advise healthcare professionals on the use of the optional Apex Hole Eliminator (Apex HE) (Part Number 124603000) with certain PINNACLE® CUP devices in their procedures, in view of a potential out-of-specification condition (oversized “minor diameter”) on certain PINNACLE® CUP devices that were manufactured from July 2017 to November 2020. The oversized condition could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of “cross-threading” if the Apex HE is manipulated or toggled while threading it through the hole of certain PINNACLE® CUP devices. Possible clinical implications related to this issue include surgical delay, poor joint mechanics and pain as well as loosening of the device. Healthcare professionals are advised to exercise care when threading the Apex HE to ensure that it is introduced perpendicular to the PINNACLE® CUP. Healthcare professionals are also recommended to continue their follow-ups on patients treated using Apex HE with the affected PINNACLE® CUP devices post-operatively according to the standard of care. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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