Stryker® Orthopedics LFIT™ CoCr V40™ Femoral Head Failure Concerns

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Robins Kaplan’s Mass Tort Department is currently investigating cases involving another Stryker Orthopedics total hip replacement component, the LFITTM CoCr V40TMFemoral Head.  Recently, a number of failed LFITTM CoCr V40TMFemoral Heads have been reported.  The failure appears to occur at the taper lock, which is the part of the hip implant that connects the femoral head (ball) to the femoral neck. 

On August 24, 2016  Health Canada (Canada’s FDA equivalent), recalled 36 mm, 40 mm and 44 mm Stryker LFITTM CoCr V40TMfemoral heads, which were manufactured prior to 2011.1  On September 27, 2016 The Australian Government, Department of Health, Therapeutic Goods Administration, issued a Hazard Alert2 to consumers and health professionals regarding the same components as the Canadian recall.

Health Canada and the Australian Government report of potential hazards associated with the device including:  disassociation of the femoral head from the hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of movement, insufficient soft tissue tension, noise, loss of implant, bone fixation strength, increased wear debris and implant construct with a shortened neck length.1, 2

The Medicines and Healthcare products Regulatory Agency (United Kingdom’s medical device safety agency) noted a Stryker URGENT Field Safety Notice (RA 2016-028) regarding LFITTM Anatomic CoCr V40TM Femoral Heads, in which all lots manufactured between January 1, 2002 and March 4, 2011 are affected 3. This notice indicates all affected products are either expired or already implanted, but asks providers to check their internal inventory so they can be quarantined and returned to Stryker.  

Patients implanted with this hip component may experience loss of mobility, pain, inflammation, ALTR (adverse local tissue reaction), dislocation, joint instability, broken bones around the components, leg length discrepancy, and the need for revision surgery 2.  If you have had a total hip replacement, and think your symptoms may be related to a taper lock failure of the Stryker LFITTM CoCr V40TMFemoral Head, call Robins Kaplan LLP at 1.800.553.9910 and speak to a Registered Nurse.

 

[1] Government of Canada.  Healthy Canadians.  Recalls & alerts.  Medical Device Recall.  LFIT CoCr V40 Head.  Howmedica Osteonics Corporation.  Model/catalog numbers:  6260-9-240; 6260-9-244; 6260-9-340; 6260-9-344; 6260-9-440; 6260-9-444.  LFIT COCR Femoral Head.  Howmedica Osteonics Corporation.  Model/catalog number: 6260-9-236 Retrieved from http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/60268r-eng.php
[2] Australian Government.  Department of Health.  Safety Information.  Alerts.  LFIT Anatomic CoCr V40 femoral heads (used in hip replacements).  Model/catalog number: 6260-9-236, head diameter 36 mm, offset +5; 6260-9-240, 40 mm, +4; 6260-9-244, 44 mm, +4; 6260-9-340, 40 mm, +8; 6260-9-344, 44 mm, +8; 6260-9-440, 40 mm, +12; 6260-9-444, 44 mm, +12.  Retrieved from https://www.tga.gov.au/alert/lfit-anatomic-cocr-v40-femoral-heads-used-hip-replacements
[3] The Medicines and Healthcare products Regulatory Agency (MHRA).  Stryker URGENT Field Safety Notice: RA 2016-028 LFITTM Anatomic CoCr V40TM Femoral Heads.  Retrieved from https://mhra.filecamp.com/public/file/2gkg-s98u2620

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Stryker® Orthopedics LFIT™ CoCr V40™ Femoral Head Failure Concerns

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