GMK Sphere Total Knee System 02.12.0313FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030862571), received between Nov 17, 2017 and Aug 25, 2022 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15292798 ↗
• InjuryMar 9, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 13MM INSERT WITH A 20MM ONE 1 YEAR AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 13711510 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP 3 YEARS AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10843094 ↗
• InjuryNov 3, 2020Unstable

  THE PATIENT CAME IN, 1 YEAR AND 2 MONTHS AFTER PRIMARY SURGERY, REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 13MM S3 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S3L - 20 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 10776613 ↗
• InjuryJul 16, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE FIRST OPERATION WAS ON (B)(6) 2015, GMK-UNI. ON (B)(6) 2016 THE GMK-UNI WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT, A GMK-SPHERE WAS IMPLANTED. ON (B)(6) 2017, DUE TO LAXITY, THE 10 MM INLAY HAS BEEN REVISED WITH A 13 MM INLAY. DUE TO PERSISTENT LAXITY PROBLEM IN EXTENSION, WITHOUT PAIN, ON (B)(6) 2020 THE TIBIA AND INLAY HAVE BEEN REVISED, A REVISION S.2 TIBIA WITH BILATERAL SHIMS (S2. 5MM), TIBIAL EXTENSION STEM (S.13 65MM) WITH OFFSET (3MM) AND REDUCTION WITH S.2 14MM INLAY WERE USED FOR THE REVISION SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 10282362 ↗
• InjuryApr 29, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY..

  Patient problems: Unspecified Infection

  MAUDE report 10009051 ↗
• MalfunctionAug 23, 2019Loose or Intermittent Connection

  ON THE (B)(6) THE SALES REPRESENTATIVE REPORTED THAT THE DEVICES ARE NO LONGER AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925183 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND SIX MONTHS AFTER THE PRIMARY. ON THE FOLLOWING DAY THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. [PATHOGEN: STREP. B].

  Patient problems: Unspecified Infection

  MAUDE report 8019267 ↗
• InjuryJul 18, 2018Unintended Movement

  REVISION SURGERY DUE TO SCREW BACK OUT 2 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGEON REMOVED SCREW AND POLY AND IMPLANTED A NEW POLY 1MM THICKER WITHOUT SCREW.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7698434 ↗
• InjuryNov 17, 2017Appropriate Device Problem Term/Code Not Available

  THE POLY WAS CHANGED OUT FOLLOWING A REPEAT WASHOUT DUE TO AN INFECTION. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7040104 ↗