GENESIS II 71421532Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010520357), received between Jul 15, 2020 and Nov 17, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Peeled/Delaminated; Material Deformation; Naturally Worn; Peeled/Delaminated; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS THAT LED TO A REVISION SURGERY BEEN PERFORMED ON (B)(6) 2021. AFTER THIS PROCEDURE, THE EXAMINATION OF THE EXPLANTED GII CR DEEP FLEX ISRT S1-2 11 M BY THE SURGEON REVEAL SOME WEAR AND A SEVERE DEFORMATION. THE SURGEON BELIEVES THAT THE INSERT EXPERIENCED A DELAMINATION. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. IT WAS CONFIRMED THAT ONLY THE INSERT WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12828768 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT HAD A TOTAL KNEE REPLACEMENT 3 YEAR AGO. PATIENT SUFFERED FROM A STIFF KNEE AND LIMITED RANGE OF MOTION 20 DEGREE - 90 DEGREE AND OVERSTUFFED PATELLA FEMORAL JOINT, THEREFORE PATIENT HAD A REVISION SURGERY, WHERE SURGEON REMOVED THE PATELLA, FEMORAL, TIBIAL INSERT AND TIBIAL BASEPLATE FROM PRIMARY SURGERY. SURGEON NOTICED THE PATELLA WAS NOT RESECTED ENOUGH, WHICH CAUSE OVER STUFFING. SURGEON ACHIEVED A RANGE OF MOTION FROM 0 DEGREES - 120 DEGREES RANGE OF MOTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 11408629 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY HAD TO BE PERFORMED TO EXCHANGE THE S1-2 11M GENESIS II CR DEEP FLEXION INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10280595 ↗