In consultation with Australian health authorities, LMT Surgical issued a warning to all surgeons who implanted the company’s PyroTitan shoulder implant, advising of a reported 3% failure rate in the devices.
The PyroTitan is a humeral resurfacing arthroplasty device designed to resurface the shoulder joint. Most confirmed breakage reports occurred within 1 year of implant and mostly as a result of "excessive loads being put on the device," according to the warning.
A couple of broken devices were returned with sub-surface fractures, which may had something to do with the high rate of breakage, according to Australia’s Therapeutic Goods Administration. LMT has temporarily stopped selling the affected devices, which includes products under 12 codes and in different sizes.
The TGA and LMT Medical advised that all patients implanted with the device be wary of pain or unusual symptoms. Excessive loads that may spur breakage included hammering, contact sports, free weights or as a result of sudden trauma. Breakage of the shoulder implant would require revision surgery.
