The metal on metal hip debacle expanded recently, with the imminent recall to be announced by Stryker Orthopedics.
According to orthopedic experts, Stryker Orthopedics will announce a new hip implant recall concerning select LFit V40 femoral heads due to higher than expected complaints of taper lock failures. These soon to be recalled Stryker hip implant femoral heads are known to be used on both Accolade TMZF and Accolade 2 stems as well as Meridian and Citation stems.
Dangerous side effects from these failures include: Disassociation of femoral head from hip stem, Fractured hip stem trunnion, Excessive metallic debris and numerous other complications, all requiring extensive and painful hip revision surgery.
Australian Stryker Hip Failure Warning
Australian health officials warned about the risk of side effects with some Stryker LFIT V40 femoral heads used during hip replacements, which have been associated with high failure rate, and raising concerns about the safety of the hip implant device worldwide.
Stryker LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 are prone to catastrophic failure and metallosis problems, which could cause patients to experience loss of mobility, pain, inflammation, local tissue reactions, dislocation, joint instability, broken bones around the components.
On September 27, the Australian Therapeutic Goods Administration warned that the modular components used in Stryker hip replacements have higher than expected rates of taper lock failures; which indicates failures where the femoral head connects to the femoral neck.
Australian officials identified item numbers for seven models of the Stryker LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm.
Stryker Recall Notice sent to doctors
Stryker recently sent a warning notice to orthopedic surgeons who have use the hip implant over the past several weeks. According to the warning, the Stryker LFIT hip implant components could cause taper lock failures due to inconsistency with the taper lock interface.
Stryker has received higher than expected complaints of taper lock failure for specific lots of the following certain sizes of LFIT Anatomic CoCr V4·0TM Femoral Heads manufactured prior to 2011.
Catalog Number Head Diameter Offset
6260-9-236 36mm +5
6260-9-240 40mm +4
6260-9-244 44mm +4
6260-9-340 40mm +8
6260·9-440 40mm +12
6260-9-344 44mm +8
6260-9-444 44mm +12
Cause of Metal Hip Failures not released by Stryker
Stryker has not disclosed the cause of the failures, either it is a manufacturing defect or this is related to a design defect that was present in 2011 or earlier.
Orthopedic doctors have reported hip failures similar to the Rejuvenate and ABGII recall that occurred in June 2012 and also reported similar failures with the V40 Cobalt/Chrome head when matched with the early version of the Accolade stem that was made of the TMZF metal alloy (TITANIUM, MOLYBDENUM, ZIRCONIUM and IRON).
Stryker hip implant failures, maybe as a result of the TMZF alloy in the recalled Rejuvenate and ABGII, that could be the common denominator on the Accolade stem too.
In 2014, many lawsuits were filed in U.S. courts indicating that patients had suffered Stryker LFIT V40 femoral head failures, alleging that the components were defectively designed and manufactured.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.