GMK Sphere Total Knee System 02.12.0211FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630030862526), received between Sep 6, 2017 and Jul 8, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER (FROM 11 TO 20 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22434260 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER WITH A THICKER ONE (FROM 11 TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20674057 ↗
• InjuryMay 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19330279 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND INSERTED CEMENT MOLD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DELAY TIME WAS 10MIN.

  Patient problems: Medical device site infection

  MAUDE report 18985055 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY. UPON PHYSICAL EXAMINATION, THE SURGEON DETERMINED THE JOINT WAS LOOSE IN FLEXION AND EXTENSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (11 TO 13 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17771756 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PATELLA PAIN AND THE CAUSE IS UNKNOWN. ABOUT 6 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND UPSIZED THE POLY DUE TO INSTABLITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15691796 ↗
• InjuryApr 20, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 11MM INSERT WITH A 14MM ONE TO GIVE THE PATIENT MORE STABILITY 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14157896 ↗
• InjuryApr 20, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 17 DAYS AFTER MEDACTA PRIMARY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT ORIGINALLY HAD COMPETITOR COMPONENTS AND WAS REVISED WITH MEDACTA COMPONENTS ON (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 14157892 ↗
• InjuryJan 26, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY ALMOST 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13356852 ↗
• InjuryJan 18, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 MONTH AND HALF AFTER THE PRIMARY SURGERY REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 11MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13280395 ↗
• InjuryJul 12, 2021Loose or Intermittent Connection

  4 YEARS 7 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A SCREW FROM THE TIBIAL INSERT HAD LOOSENED. THE SURGEON REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12149874 ↗
• InjuryAug 3, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 10354784 ↗
• InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS STREPTOCOCCUS MITIS. THE SURGEON PERFORMED AN I & D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND 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 10331334 ↗
• InjuryJul 26, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR AN INFECTION CASE. LINER SWAP PERFORMED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8830087 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE INSERT, RESURFACED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8217183 ↗
• InjuryNov 7, 2018Malposition of Device

  ABOUT 1 YEAR AFTER PRIMARY THE SURGEON REVISED THE PATIENT SWAPPING THE INSERT. THE LINER FIXATION SCREW WAS BACKED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8045550 ↗
• InjuryApr 6, 2018Device Slipped

  INLAY LOCKING SCREW ARTHROSCOPIC REMOVAL DUE TO UNSCREWING AFTER 1 YEAR AND 8 MONTHS FROM PRIMARY. TORQUE LIMITER SCREWDRIVER WAS NOT USED DURING PRIMARY SURGERY.

  Patient problems: No Code Available

  MAUDE report 7402521 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT 10 MONTHS AFTER PRIMARY COMPLAINING OF POOR RANGE OF MOTION. THE SURGEON REVISED THE 11MM INSERT FOR A 10MM ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7341163 ↗
• InjurySep 6, 2017Device Issue; Device Issue

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SCREW BACKED OUT OF THE POLY. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Pain

  MAUDE report 6844611 ↗