Recalled Sulzer Inter-Op Shells
The Sulzer Inter-Op acetabular shells affected by the recall are listed on the chart below.
If you are unsure if you have a recalled product, please contact us and we will help determine whether you need to be concerned.
|
|
Product |
|
|
| 4360-00-039/065 | Hemispherical Shells | 1307848 | 1465372 |
| 4361-00-039/071 | Rim Flare Shells | 1398234 | 1465247 |
| 4362-00-043/081 | Revision Shells | 1397531 | 1465242 |
| 4363-00-053/081 | Protrusio Shells | 1403576 | 1453540 |
What caused the recall of the Inter-Op shell?
Some of these implants had an unacceptable level of mineral oil-based
lubricant on the product. Based on the expertise of some independent
scientists, this residue may cause adverse reactions in the body
that can lead to loosening of the shell.
What are the components of the lubricant residue?
There are five mineral oil based lubricants used in the machines to manufacture these parts. These include Mobil DTE 24, Mobil Velocite Oil No. 8, Mobil Velocite Oil No. 6, Mobil Vactra Oil No. 2, and Mobil Vactra Oil Heavy.
Where can I find more data or Material Safety Data Sheets (MSDS) on the lubricants?
The implant uses 5 mineral-oil based lubricants in the machines to manufacture the Inter-Op shells. All five are made by Mobil.
The Mobil products are:
DTE 24
Velocite Oil No. 8
Velocite Oil No. 6
Vactra Oil No. 2
Vactra Oil Heavy
How could this happen in the manufacturing process?
Sulzer's investigation indicated that a small amount of mineral oil-based lubricant leaked into the machine coolant and residual amounts of this lubricant remained on the shell after the cleaning process.
How many shells have been implanted? How many of those have been recalled?
The actual affected product lots included approximately 25,000 parts. 17,500 of the affected products were implanted. All remaining affected products were recalled.
Did the manufacturer use a different process to make the Inter-Op shell than for Sulzer's other products?
Yes. Parts not included in the recall are manufactured by a different process.
What steps should surgeons take for patients with a recalled Inter-Op shell?
The FDA does not require the surgeon to contact the patient. However, it is Sulzer's recommendation that surgeons contact patients that received Inter-Op shells from an affected lot, if the surgeon deems appropriate. Sulzer is doing everything possible to deliver the appropriate information to relevant parties.
How can a patient or surgeon tell if there are problems with an Sulzer Inter-Op shell implant?
Be aware of symptoms which may includ ethe following:
Up to 6 weeks:
The patient may be progressing well or reporting groin or anterior trochanteric pain.
The patient may have increased thigh pain.
Patient has significant startup pain with ambulation or, rising from a seated position, may have buttock pain.
An x-ray may show possible component migration.
6 weeks to 3 months:
Significant pain with weight bearing, may require cane or crutch.
Patient cannot exert resistance in straight raised leg test and side-lying abduction test.
At 3 months:
Sometimes only a Lauenstein lateral x-ray shows a nearly complete radiolucent line around the acetabular component 1mm or more in thickness and possible component migration may not be seen on AP x-ray.
No evidence of infection has been found preoperatively in
sedimentation rate, c-reactive protein or aspiration. All cultures
at surgery are negative; an arthrogram may not show dye around
the shell.
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