Stryker Hip Problems
Stryker, a leading manufacturer of hip replacement devices, currently faces a bevy of complaints regarding several of its hip devices. The Trident and Rejuvenate product lines have received the most criticism, including reports of Stryker hip problems like faulty implants, broken components, improper fittings, and squeaky joints that may force patients to undergo a Stryker hip revision surgery. As a result, the company has implemented hip recalls for several products, although this action has not halted the quickly growing number of Stryker hip implant lawsuit complaints.
Injured patients filed Stryker hip implant lawsuit complaints
Since 2005, the Food and Drug Administration (FDA) has received complaints of Styker hip problems, for both the Rejuvenate and Trident hip systems. Patient complaints include:
- Squeaky joints: A study published in Orthopedics Today concluded that 11.4% of ceramic-on-ceramic implant recipients experience squeaking, often loud enough to require revision surgery.
- Faulty implants: Both systems are reportedly plagued by broken component parts, corrosion and uneven wear, both of which can cause pain or device failure.
- Pain and discomfort: Implant recipients complaint of pain, either general site discomfort or pain related to faulty implant components.
- Bone fractures: Due to improper fittings, some patients have allegedly experienced fractured bones.
- Metal poisoning: The Rejuvenate implant, which features a metal-on-metal design, is thought to leech metal fragments into the bloodstream and surrounding tissues, causing a form of heavy metal poisoning known as metallosis.
Injured implant recipients have filed Stryker hip implant lawsuit complaints against the manufacturer. Currently, qualifying Trident lawsuits have been centralized in the New Jersey Superior Court of Atlantic County, where experienced mass tort Judge Carol Higbee presides. Cases involved the Rejuvenate system, a younger implant, have not yet been consolidated.
Stryker hip problems strike two product lines
In February 2003, the FDA approved the Stryker Trident hip system, which utilized ceramic-on-ceramic component parts. By 2007, the FDA stepped in and launched an investigation of Stryker’s Trident manufacturing facilities in New Jersey and Cork, Ireland. As a result, the FDA issued two warning letters to the company, the first of which detailed several violations at the Cork plant, and the second revealing deficiencies at the New Jersey manufacturing site. Among other findings, the agency concluded, “that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.”
In June 2008, the FDA approved Stryker’s Rejuvenate system, a metal-on-metal product hip implant. By April 2012, the company conceded that its Rejuvenate Modular Stems was problematic, and issued an Urgent Field Safety Notice for Corrective Action. At the time, the company detailed several Stryker hip problems, including “excessive metal debris and/or ion generation,” “excessive fretting (deterioration),” and a possible “need for revision surgery.”
Stryker hip recall issued by manufacturer
In January 2008, Stryker issued a voluntary recall of the Trident Hemispherical and Trident Acetabular PSL cups manufactured in its Cork facility. Four years later, in July 2012, the company issued a complete voluntary recall of its Rejuvenate Modular and ABG modular neck hip implants. In explanation, the company stated that, “This voluntary recall was initiated due to the potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.”
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