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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00922-1
Product Name/Description	TANDEM INTL BIPOLAR 46OD 28ID Product Code: 71324046 Lot Number: W2401399 Expiry Date: Jan-Feb 2034 ARTG 242993 (Smith & Nephew Pty Ltd - TANDEM INTL Bipolar - Femoral head bipolar component)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/10/2024
Responsible Entity	Smith & Nephew Pty Ltd
Reason/Issue	It was identified that the metal retainer ring included in a batch of TANDEM INTL BIPOLAR 46OD 28ID was too big. This results in a reduced retention force of the Bipolar assembly. In the worst-case scenario, the surgeon assembles the Bipolar assembly during surgery. Then based on the tolerance stack, there is likely interference between the Retainer Ring and the Lock Ring that holds the assembly together, although the interference and associated retention force of the assembly would be less than the design intent. The surgeon doesn’t notice the reduced retention force of the ring in the shell, and the device is implanted. The patient is mobile and active, pushing the implant into eccentric loading and the implant disassociates during use. This results in a loss of function of the joint, pain, instability and impingement with loose bodies in the joint resulting in revision surgery.
Recall Action	Hazard Alert
Recall Action Instructions	Physicians are to be aware of this problem and maintain their routine patient follow-up protocol.
Contact Information	Katherine.StaAna@Smith-Nephew.com - Smith & Nephew Pty Ltd