PROFEMUR Neck VAR/VAL 8DG Long Cobalt Chrome Neck (2015-08-07)

Starting date:

August 7, 2015

Posting date:

September 1, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-54858

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  Reason
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  Affected products

Affected Products

1. PROFEMUR Neck VAR/VAL 8DG Long Cobalt Chrome Neck

Reason

MicroPort Orthopedics Inc. is voluntarily recalling profemur long cobalt chrome 8 degree varus/valgus modular neck, part number Phac1254. This product is used with modular hip stems during total hip Arthroplasty surgery. MicroPort Orthopedics Inc. has received reports of an unexpected rate of postoperative fractures related to this specific part number. All lot numbers may be affected. Further distribution or use should cease immediately.There is no evidence fractures can be anticipated by visual inspection or during surgery. When the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks. It is expected the patient will recognize immediately that the device is not functioning properly and seek medical attention. A fracture will require revision surgery to remove and replace the neck and stem components.

Affected products