GMK Sphere Total Knee System 02.12.0511FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07630030862663), received between Oct 31, 2017 and Jul 24, 2024 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 7 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19814525 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH A THICKER ONE (FROM 11 MM TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18003498 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS POST PRIMARY THE SURGEON REVISED THE PATIENT'S KNEE FOR PAIN AND KNEE LOOSENESS. THE LINER WAS SWAPPED TO A THICKER ONE (FROM 11 MM TO 13 MM) AND THE PATELLA BONE WAS RESURFACED WITH A PATELLA IMPLANT.

  Patient problems: Joint Laxity

  MAUDE report 17823103 ↗
• InjuryJul 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17404475 ↗
• InjuryJul 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17396663 ↗
• InjuryJul 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO INTRA-PROSTHETIC DISLOCATION OF THE LINER FROM THE TIBIAL TRAY. THE SURGEON REPORTED THAT THE LINER WAS NOT PROPERLY ENGAGED DURING THE PRIMARY SURGERY. ONLY LINER REVISED WITH A 10MM LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360881 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO AN MCL SPRAIN AND THE CAUSE OF THE SPRAIN IS UNKNOWN. WHEN THE SURGEON OPENED UP THE PATIENT THE SURGEON ALSO OBSERVED LAXITY. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A POLY SWAP (FROM 10MM TO 13MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16960278 ↗
• InjuryMar 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Unspecified Infection

  MAUDE report 16502155 ↗
• InjuryDec 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 8 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15959138 ↗
• InjuryOct 27, 2022Adverse 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 AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT - FLEX S5R - 12MM WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5R - 20MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15679056 ↗
• InjurySep 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15400679 ↗
• InjurySep 8, 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND 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, REMOVED ALL IMPLANTS AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15376732 ↗
• InjuryJul 18, 2022Unstable

  AT ABOUT 2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT (11MM) WITH A THICKER ONE (13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15040358 ↗
• InjuryJun 21, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, 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. 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 14751850 ↗
• InjuryJun 17, 2022Unstable

  AT 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH A THICKER ONE (FROM 11MM TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14732954 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 11 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  MAUDE report 13768213 ↗
• InjuryJan 25, 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 17 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13342902 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN HAS BEEN IDENTIFIED AS E. COLI. 2 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bacterial Infection

  MAUDE report 12015281 ↗
• InjuryMay 19, 2021Loose or Intermittent Connection

  5 YEARS AND 2 MONTHS AFTER PRIMARY THE LINER FIXATION SCREW HAD LOOSENED. THE CAUSE OF THE SCREW LOOSENING IS UNKNOWN. THE SURGEON REMOVED THE SCREW AND DID NOT REVISE ANY IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11847279 ↗
• InjuryMar 9, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. 2 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S5 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S5R - 17MM TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11444816 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 6 MONTHS AFTER THE PREVIOUS REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PREVIOUS REVISION SURGERY WAS PERFORMED DUE TO INFECTION (WASHOUT AND LINER REVISION PERFORMED). THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 11420960 ↗
• InjuryFeb 9, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS STAPHYLOCOCCUS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11300309 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 14 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10842094 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 3 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10579079 ↗
• InjuryAug 28, 2020Unexpected Therapeutic Results

  THE PATIENT CAME INTO THE CLINIC AFTER 8 MONTHS. HE IS A TRUCKDRIVER AND IT IS NOT POSSIBLE FOR HIM TO GET THE PERFECT FLEXION IN THE KNEE. HE CAN`T REACH 90° AND HE HAS PATELLA PAIN. THE PATELLA IS VERY THICK REGARDING (THE PATIENT HAS ARTHROLYSE). THE SURGEON WANTS TO IMPLANT A PATELLA AND PERHAPS TO REVISE THE INLAY FROM 11MM TO 10 MM. THE SURGERY IS PLANNED ON (B)(6) 2020.

  Patient problems: Joint Disorder; Limited Mobility Of The Implanted Joint

  MAUDE report 10464588 ↗