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News & Trends - MedTech & Diagnostics

MicroPort Orthopedics’ titanium modular necks pose risk of fracture

Health Industry Hub | August 31, 2020 |

MedTech News: MicroPort Orthopedics, in consultation with the TGA, has initiated a hazard alert for all lot numbers of Profemur Long and Extra-Long Titanium Modular Necks due to the risk of the implant fracturing.

Profemur Titanium Modular Necks are a component used in some hip replacement procedures.

A component with the potential to fracture cannot be detected during surgery or by visual inspection or any other diagnostic technique. While fractures are rare, should one occur the patient may experience sudden pain, instability and difficulty walking/performing common tasks.

The total global fracture rate of Long and Extra-Long Profemur Titanium Modular Necks is currently 0.552 per cent. The fracture rate in Australia is currently 0.997 per cent with six fractures reported in Australia from 2002 to 2019.

Profemur Titanium Long and Extra-Long Modular Necks have not been used in Australia since 2012 and were cancelled from the Australian Register of Therapeutic Goods (ARTG) in 2015.

No other MicroPort Orthopedics products are included in this hazard alert.

The fractured components occur when stresses produced at the modular neck/stem taper interface in heavy and/or highly active patients in whom predominantly longer offsets can exceed the fatigue strength of the modular neck.

MicroPort Orthopedics has written to all surgeons who have received supplies of the affected components to advise them of the hazard alert.

Surgeons are advised that MicroPort Orthopedics does not recommend prophylactic revision surgery, but does advise continuing to monitor the relevant patients according to the standard follow-up protocol.

The affected lots are:

  • PHA01204 Profemur neck NEUTRAL – LONG
  • PHA01214 Profemur neck A/R VAR/VAL 2 – LONG
  • PHA01224 Profemur neck A/R VAR/VAL 1 – LONG
  • PHA01234 Profemur neck 8DG A/R – LONG
  • PHA01244 Profemur neck 15DG A/R – LONG
  • PHA01254 Profemur neck 8DG VAR/VAL – LONG
  • PHA01264 Profemur neck 15DG VAR/VAL – LONG
  • PHA01206 Profemur neck NEUTRAL – EXTRA LONG
  • PHA01236 Profemur neck 8DG A/R – EXTRA LONG
  • PHA01256 Profemur neck 8DG VAR/VAL – EXTRA LONG

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