Individuals who have undergone implantation of certain replacements from Exactech, Inc. require additional procedures to repair the damage caused by the defective devices.
In 2021, medical device manufacturer Exactech, Inc., recalled the Exactech Connexion GXL acetabular polyethylene liner hip component used in its hip implant systems because of the possibility of premature liner wear.
Company’s reactions
On February 7, 2022, Exactech sent an Urgent Medical Device Correction notice to knee and ankle surgeons, hospitals, and health care professionals. The company has expanded its August 31, 2021, recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in nonconforming bags regardless of label or shelf life.”
Exactech has not directly notified individuals who received the recalled knee, ankle, or hip replacements. Rather, the company provided a template letter for surgeons, who were asked to send the letter to any patient who might have been affected by the defective medical devices.
Recipients of ankle, knee, and hip replacements can visit Exactech’s online tool to determine whether their replacement has been recalled. Recipients will need to enter the serial number of their device, which can be found in their medical records.
Main problem
In 2004, Exactech began packaging inserts in nonconforming vacuum bags that lacked a secondary barrier layer of ethylene vinyl alcohol (EVOH). Without EVOH to augment the oxygen resistance of the inserts, the devices were subject to oxidation and premature wear when implanted.
According to Exactech, inserts manufactured since 2004 have been packaged in nonconforming vacuum bags. Although the bags are oxygen resistant, they do not feature a secondary barrier layer of EVOH. The purpose of EVOH is to bolster the device’s resistance to oxygen.
Because of this lowered resistance, oxygen diffuses to the ultra-high-molecular-weight polyethylene (UHMWPE) insert, causing increased oxidation of the material, as compared with inserts packaged with the secondary barrier layer.
Side effects
• Accelerated production of wear debris
• Bone loss
• Disintegration of bone cells (lysis)
• Pain
• Loosening
• Component fatigue cracking/fracture
• Necessary corrective revision surgery
Impact
According to Exactech’s notice, 147,732 inserts implanted in the United States since 2004 were produced with nonconforming packaging. The recall comprises all nonconforming Exactech knee and ankle UHMWPE inserts in the field, regardless of shelf life.
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