Medical device manufacturer, DePuy, has issued a medical device safety alert concerning its Pinnacle CUP devices. This voluntary Field Safety Notice is ONLY directed to users of the optional Apex Hole Eliminator (Apex HE) (Part Number 124603000) with certain PINNACLE CUP devices.
The affected PINNACLE CUP devices are as follows:
According to the manufacturer, there is a potential of an out of specification condition (oversized "minor diameter") on the abovementioned PINNACLE CUP devices. This defect is limited to lots that were manufactured on one specific machine tool in the manufacturing facility from July 2017 to November 2020.
The manufacturer is alerting physicians who use the Apex HE that the oversize condition of the hole in the cup could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally because of "cross-threading". This may occur if the Apex HE is manipulated or toggled while threading it through the hole of those PINNACLE CUP devices. If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
Possible clinical implications may include the following:
Physicians are advised to exercise care when threading the Apex HE to ensure that it is introduced perpendicular to the PINNACLE CUP. If threaded properly, the Apex HE should engage normally with the cup as intended. It is only when the Apex HE is toggled or pushed off axis while threading that there is a potential for cross-threading.
Physicians who have treated patients using Apex HE with the affected PINNACLE CUP devices should continue to follow up on those patients post-operatively according to the physician's standard of care.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 24 December 2020