BoneSmart
Administrative Staff
- Joined
- Jun 11, 2013
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United States
Revised March 6, 2021 by Jamie
Please note that this recall was quite some time ago and has been resolved.
In simple terms, surgeons have reported/complained that fitting the plastic spacer into the knee, which is invariably a tight fit, it was sometimes so tight there was a risk of damage to the plastic surface. When this happens, another implant package must be opened, adding cost to the procedure. This was likely the surgeon's complaint that generated the recall. It would be hypothesized that, should such a damaged insert have been used in the knee, it could have resulted in a need for early revision, which is true. It would be unlikely that any surgeon would have implanted a damaged spacer, as they are generally extremely vigilant about things like this. Even if a damaged spacer were to be used, the need for early revision still might not be an inevitability as it would depend upon the nature and position of any damage.
As a result of this complaint, Zimmer added a special tool to the instrument set to make placement of the spacer easier as stated in the underlined text below.
Link to FDA Notice November 13 2009
Reason for Recall: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action: An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a change to the surgical technique, to include the use of a new peripheral rib impactor tool so any of these devices installed since January 2010 should be fine.
Please note that this recall was quite some time ago and has been resolved.
In simple terms, surgeons have reported/complained that fitting the plastic spacer into the knee, which is invariably a tight fit, it was sometimes so tight there was a risk of damage to the plastic surface. When this happens, another implant package must be opened, adding cost to the procedure. This was likely the surgeon's complaint that generated the recall. It would be hypothesized that, should such a damaged insert have been used in the knee, it could have resulted in a need for early revision, which is true. It would be unlikely that any surgeon would have implanted a damaged spacer, as they are generally extremely vigilant about things like this. Even if a damaged spacer were to be used, the need for early revision still might not be an inevitability as it would depend upon the nature and position of any damage.
As a result of this complaint, Zimmer added a special tool to the instrument set to make placement of the spacer easier as stated in the underlined text below.
Link to FDA Notice November 13 2009
Reason for Recall: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action: An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a change to the surgical technique, to include the use of a new peripheral rib impactor tool so any of these devices installed since January 2010 should be fine.
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