GENESIS II 71420622Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010208538), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE KNEE BECAME SYMPTOMATIC SINCE, AT LEAST, 2020. ABOUT THREE WEEKS AGO, A CRACKING NOISE WAS HEARD, SO A RADIOLOGICAL IMAGE WAS TAKEN TO CHECK IF AN IMPLANT FRACTURED. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO ADDRESS THE FRACTURE OF GII CONV W/TAPER SZ 6 RT. THE TOTAL KNEE ENDOPROSTHESIS WAS EXPLANTED: BONE DEFECTS AND MASSIVE METALLOSIS WERE FOUND INTRA-OPERATIVELY; EXTRACTION OF STEM WAS ONLY POSSIBLE WITH BONE FENESTRATION. A SPACER WAS IMPLANTED SO REIMPLANTATION SURGERY IS STILL PENDING. PATIENT CURRENT HEALTH STATUS IS NOT KNOWN.

  Patient problems: Arthralgia; Discomfort; Failure of Implant; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 13700152 ↗