GMK Sphere Total Knee System 02.12.0511FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630030862649), received between May 2, 2018 and Apr 23, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND I&D, THEN REVISED THE 11 MM INSERT TO A 14 MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24964783 ↗
• InjuryJun 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL MEDACTA HARDWARE AND RE-IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19603595 ↗
• InjuryJun 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY FOR KNEE LOOSENESS. THE CAUSE IS UNKNOWN. REVISION SURGERY AT ABOUT 2 YEARS AND 11 MONTHS POST PRIMARY. THE SURGEON DECIDED TO UPSIZE THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19603482 ↗
• InjuryMay 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN. FROM THE X-RAYS NO IMPLANT LOOSENING OR OTHER ISSUES HAS BEEN DETECTED. THE SURGEON DECIDE TO PERFORM THE PATELLAR RESURFACING (PATELLA SIZE 3 IMPLANTED) AND THE LINER WAS REVISED WITH A THICKER ONE (13MM).

  Patient problems: Implant Pain

  MAUDE report 19371769 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (11 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17975677 ↗
• InjurySep 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 9 MONTHS FROM 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: Medical device site infection

  MAUDE report 17668784 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS AND A HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT, IMPLANTING A 3MM THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17350436 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS DUE TO THE FORMATION OF EXCESS SCAR TISSUE. THE SURGEON REMOVED SCAR TISSUE AND SWAPPED THE POLY (11 TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16635903 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PATELLA FEMORAL JOINT PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 5 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATIENT'S NATURAL PATELLA AND UPSIZED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15536921 ↗
• InjurySep 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMUR AND POLY. 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 15408867 ↗
• InjuryAug 3, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE INSERT (11MM) WITH A THICKER ONE (14MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15154693 ↗
• InjuryJun 30, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD KNEE PAIN AND A FEELING OF MID-FLEXION INSTABILITY. ABOUT 1 MONTH AND A HALF AFTER THE PREVIOUS SURGERY, THE SURGEON CHANGED TO A THICKER INLAY. THE PATIENT HAD THE PRIMARY SURGERY ON (B)(6) 2013 AND ALREADY HAD TWO REVISION SURGERIES, ON (B)(6) 2014 AND ON (B)(6) 2022.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14873815 ↗
• InjuryDec 17, 2021Appropriate Device Problem Term/Code Not Available

  AT 2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON IMPLANTED A COMPETITOR PATELLA IMPLANT DUE TO PAIN AND PERFORMED LINER REVISION DUE TO LAXITY (THE SURGEON IMPLANT A LINER 1MM THICKER THAN THE REVISED ONE).

  Patient problems: Joint Laxity; Pain

  MAUDE report 13024859 ↗
• InjuryNov 30, 2021Appropriate Device Problem Term/Code Not Available

  AT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 11 MM INSERT TO A 13 MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12890177 ↗
• InjuryJun 7, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  3 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING LAXITY. THE SURGEON REVISED THE 11MM INSERT WITH A 13MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11946154 ↗
• InjuryMay 28, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 11MM INSERT WITH A 12MM ONE 28 DAYS AFTER PRIMARY TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11900864 ↗
• InjuryJan 20, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX LEFT 11MM S5 WITH A SPHERE INSERT FLEX LEFT 11MM S5 10 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9605406 ↗
• InjuryJul 17, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 10 MONTHS AFTER THE PRIMARY DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8797319 ↗
• InjuryJan 30, 2019Unstable

  THE PATIENT CAME IN DUE TO A FALL 8 MONTHS AFTER PRIMARY. THE SURGEON REVIEWED THE PATIENT AND DETERMINED THAT INSTABILITY WAS THE CAUSE OF THE FALL. A REVISION WAS PERFORMED AND THE 02.12.0511FL SIZE 11MM S5 WAS REMOVED AND REPLACED WITH A 02.12.0517FL 17MM S5.

  Patient problems: Fall

  MAUDE report 8288677 ↗
• InjuryNov 19, 2018Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER PRIMARY SURGERY. THE PATHOGEN WAS IDENTIFIED AS (B)(6). THE SURGEON PERFORMED AN I&D AND A POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 8084553 ↗
• MalfunctionMay 8, 2018Malposition of Device

  DURING SURGERY THE INSERT WOULD NOT SEAT INTO THE TIBIAL BASEPLATE: A SECONDARY INSERT (LOT 155786) WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494710 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 WEEKS AFTER PRIMARY. THE PATHOGEN IS CONFIRMED AS INTER COCCUS. THE SURGEON PERFORMED AN I AND D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7479658 ↗