GMK Sphere Total Knee System 02.12.0213FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030862533), received between Nov 23, 2017 and Apr 30, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE WAS UNKNOWN. ABOUT 4 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON RESURFACED THE PATIENT'S PATELLA AND REVISED THE POLY (FROM 13 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19213121 ↗
• InjuryDec 17, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO 2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY. THE 13MM GMK SPHERE POLY LINER WAS EXCHANGED FOR A 20MM LINER, AS THE PATIENT HAS DESCRIBED A FEELING OF INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 11030155 ↗
• InjuryApr 5, 2018Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO INTRA-PROSTHETIC DISLOCATION AFTER ABOUT ONE WEEK FROM THE PRIMARY. DURING THE FINAL IMPACTION OF THE TIBIAL BASEPLATE, IN THE PRIMARY SURGERY, THE SURGEON NOTED PARTIAL AVULSION OF THE MCL. HE PROCEEDED TO REPAIR WITH STAPLE AND ANCHORS, NO OTHER COMPLICATIONS WERE NOTED DURING THIS CASE. AFTER ABOUT ONE WEEK FROM THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH KNEE PAIN AND COULD FEEL A ''CLICKING'' SENSATION. WITH TESTING, THERE WAS LAXITY OF THE MCL AND X-RAYS REVEALED THAT THE TIBIAL INSERT WAS DISLODGED. THE REVISION CASE CONSISTED OF A TIBIAL INSERT EXCHANGE AND MCL INTERNAL BRACE WITH 6 ANCHORS.

  Patient problems: Joint Disorder

  MAUDE report 7398902 ↗
• InjuryMar 2, 2018Device Dislodged or Dislocated

  ON (B)(6) 2018 SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE SCREW BACKED OUT OF THE POLY. REVISION SURGERY PERFORMED ON (B)(6) 2018 DUE TO SCREW BACKED OUT OF THE INSERT. THE SCREW WAS NOT IMPLANTED USING A TORQUE LIMITING DRIVER. THE SURGEON IMPLANTED A NEW SCREW WITH THE INSERT. HE DID USE A TORQUE DRIVER THIS TIME AROUND.

  Patient problems: Pain

  MAUDE report 7309745 ↗
• InjuryNov 23, 2017Device Dislodged or Dislocated

  THE PATIENT CAME IN DUE TO DISLOCATION ANTERIOR TO THE TIBIA. THE CAUSE OF DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE POLY FROM A SIZE 2 13MM MOVING TO A SIZE 2 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7057077 ↗