Stryker Hip Lawsuit

Stryker Hip FDA Recall Leads to Stryker Hip Lawsuit claims. Potentially serious complicatins with Stryker hip implants date back years from indications in FDA Reports..  On November 28, 2007, Stryker Orthopaedics Corp received a Warning Letter from the Food and Drug Administration’s (FDA) Inspections, Compliance, Enforcement and Criminal Investigations division. The impact, if any, of this long history of problems may have on the Stryker Hip Repalcement lawsuit multidistrict litigation is yet to be seen. Many a Stryker Hip lawyer are closely investigating and reporting on all Stryker Hip FDA warnings to help alert the public.

The warning letter sent to Stryker Orthopaedics Corp in 2007 may have been the result of a number of adverse events reported to the FDA between early 2005 and early 2007, say reports.  The FDA following an inspection of Stryker Howmedica Osteonics Corp. sent their warning letter which specifically targets Stryker hip implants and says “During the inspection of your firm, Stryker Howmedica Osteonics Corp., located at 325 Corporate Drive, Mahwah, New Jersey on June 1, 2007 through July 12, 2007, our investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ReUnion Plasma Spray Humeral Stem, Solar Plasma Purefix HA Shoulder Stems, Trident PSL Acetabular Shells, Duracon Toatal Knee Modular Femoral Component, hip implant components (Trident PSL HA Solid Black 52 MM, Trident Hemispherical Cluster 50 MM), hip implants with ceramic bearing components, and Global Modular Hip Stems.”

Says the FDA of their visit  “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in 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 found at Title 21, Code of Federal Regulations (C.F.R.), Part 820.”

A year later in 2008 a Stryker Hip recall was issued involving the Trident Acetabular PSL Cup and the Trident Hemispherical Cup. The company responded to the recall by defending their manufacturing process and products.  Stryker has allegedly stated none of the Stryker Hip recall products involved had been implanted.  However; the problems do not stop in 2007 or 2008.

On July 6, 2012 The FDA issued a press release about yet another Stryker Hip recall. This time the Stryker Hip recall was voluntary and isolated to specific component parts of Stryker Hip implants. The FDA press release says “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Action Specific to Rejuvenate and ABG II Modular-Neck Stems”.  This action potentially strengthens the position of plaintiffs that have alleged injury and subsequently had a Stryker Hip lawyer file a Stryker Hip lawsuit. The Stryker hip lawsuit has been consolidated into a multidistrict litigation with hearings planned.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076583.htm

http://www.fda.gov/Safety/Recalls/ucm311043.htm

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241770.htm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1357869