Stryker Howmedica Osteonics is the orthopaedic implant
division of Stryker Corporation. Around 20 million Americans have
osteoarthritis, which often occurs in the hip joint. When the cartilage
has worn thin because of it, a hip replacement surgery may be necessary.
Stryker Howmedica Osteonics has a range of primary femoral hip
components that are used for surgical implants.
In September 2001, the FDA announced a hip implant recall due
to a potential fracture problem. The French manufacturer St. Gobain
Desmarquest recalled the zirconia ceramic femoral head component in
August 2001 after noticing it was fracturing at a higher rate than
expected in some patients just 13-27 months after being implanted. At
the time of the recall, other medical manufacturers, including Stryker
Howmedica Osteonics, used the French medical device products.
The U.S. companies had estimated the hip implants with zirconia
ceramic femoral heads are used in less than 6% of the hip implant
procedures in the U.S., with an estimated 150,000-200,000 hip implants
performed every year in the U.S. If affected Stryker Howmedica implants
were used, the patient would experience sudden pain in the implanted hip
joint. In some instances, the pain was preceded by a "pop" noise from
Since each additional operation increases the risk of the hip
implant not lasting, the affected Stryker Howmedica implants threatened
the long term well being of patients. The 2001 hip replacement recall
affecting Stryker Howmedica was the second large hip replacement recall
within a couple years. Even though not every one of the recalled
Howmedica hips was believed to be problematic, the FDA medical officer
had advised all patients to move on the side of caution since the
complications could be significant.
The hip implant recall affected Stryker Howmedica zirconia
ceramic femoral heads that had been manufactured since January 1998. Hip
replacement surgery is a major procedure that involves hospitalization,
rehabilitation, a large amount of discomfort, and relearning how to
walk with the implanted hip, so re-operation can be devastating news to a
patient. The FDA recommended the Howmedica hip implant patients to
contact their physicians since there was an absence of tests available
to predict which recalled models would fail.
After the first major hip replacement recall involving Sulzer
Orthopedics, lawsuits were filed due to the devastating effects it left
on some patients. In 2000, a National Institutes of Health panel
reported that more studies needed to be performed on what happens to
medical devices after they are implanted into patients. The hip
replacement recall involving Howmedica and the other companies using the
St. Gobain manufactured components was another indication that
improvements in patient safety can always be made.