GMK Sphere Total Knee System 02.12.0005RRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07630030825866), received between Dec 14, 2018 and Dec 27, 2024 — classified as 23 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PRIMARY SURGERY PERFORMED ON THE (B)(6) 2024. 1ST REVISION SURGERY PERFORMED ON THE (B)(6) 2024. THE PATIENT WAS REVISED DUE TO INFECTION. WASHOUT AND LINER REVISED AS PER STANDARD PROCEDURE. 2ND REVISION SURGERY PERFORMED ON THE (B)(6) 2024. EXPLANTATION OF ALL COMPONENTS DUE TO INFECTION. PLACEMENT OF A SPACER AND ANTIBIOTIC THERAPY FOR 6 WEEKS. REASSESSMENT OF THE SITUATION IN (B)(6) 2025.

  Patient problems: Medical device site infection

  MAUDE report 21026657 ↗
• InjuryDec 11, 2024Device Appears to Trigger Rejection; Device Dislodged or Dislocated; Device Appears to Trigger Rejection; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. SUBSEQUENTLY, THE PATIENT HAD SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE POLY. ON (B)(6) 2024, THE HAD PAIN, DUE TO A DEFICIENT MCL AND A DISLOCATION OF THE PATELLA IMPLANT. THE KNEE WAS INFECTED. THE SURGEON EXPLANTED THE PATELLAR IMPLANT, REVISED THE FEMORAL COMPONENT AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 20900786 ↗
• InjuryJun 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT ABOUT 6 YEARS AND 10 MONTHS POST PRIMARY DUE TO TIBIAL AND FEMORAL COMPONENTS LOOSENING. NO CEMENT ON FOUND ON THE IMPLANT DURING THE REVISION. THE PATIENT WAS INSTABLE AND THERE WAS DEVICES MALALINGNMENT. GMK REVISION SYSTEM IMPLANTED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19527700 ↗
• InjuryDec 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 3 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE INFECTION CASUED THE LOOSENING OF THE IMPLANTS. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18324594 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF INSTABILITY. ALL THE COMPONENTS HAVE BEEN REVISED WITH COMPETITOR COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 17886293 ↗
• InjuryMar 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. AT ABOUT 4 MONTHS FROM THE PRIMARY THE SURGEON REMOVED THE IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16618194 ↗
• InjurySep 14, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY DUE TO FEMUR LOOSENING, THE SURGEON OBSERVED THAT THE FEMUR SEEMED TO BE OVERSIZED. IT WAS REVISED THE FEMUR AND INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15418325 ↗
• InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON OBSERVED THAT THE PATIENT HAD AN ALLERGIC REACTION. THE SURGEON SWAPPED ALL DEVICES AND IMPLANTED SENSITIN REVISION KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT DIDN'T ANTI-ALLERGIC TEST BEFORE THE SURGERY.

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 14684878 ↗
• InjuryMay 10, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND SWELLING. THE SURGEON DECIDED TO REVISE THE PATIENT AND DISCOVERED THAT ALL IMPLANTS WERE LOOSE AND DID NOT BOND WITH THE CEMENT. THE CAUSE OF THIS IS UNKNOWN. AT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14346313 ↗
• MalfunctionApr 21, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A KNEE REPLACEMENT SURGERY, A GMK SPHERE FEMORAL COMPONENT IMPLANT BOX SIZE 5R WAS OPENED. THE COMPONENT WAS INSERTED WITH CEMENT UPON WHICH THE SURGEON NOTICED A DISCREPANCY BETWEEN THE TRIAL AND THE DEFINITE IMPLANT, AND THEN DISCOVERED THAT IT WAS A LEFT FEMORAL COMPONENT. THE GMK SPHERE FEMORAL COMPONENT HAD TO BE REMOVED, THE CEMENT WAS SCRAPED AWAY TO CHECK THE SIZE LABEL INSIDE THE COMPONENT. INSTEAD OF A 5R AS PER THE LABEL ON THE BOX AND INSIDE THE PACKAGE, IT WAS A 6L. BECAUSE THERE WAS NO BACK-UP SET AVAILABLE, ANOTHER 5R HAD TO BE BROUGHT TO THE HOSPITAL FROM THE SOUTH AUSTRALIAN WAREHOUSE. THE SURGERY GOT DELAYED BY AT LEAST 40MIN, BUT WAS THEN SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167012 ↗
• InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13152733 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12852078 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available

  AT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT HAD REVISION SURGERY DUE TO PAIN AND KNEE INSTABILITY. ALL IMPLANTS WERE REVISED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12758722 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem

  2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY A SECOND REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON REVISED ALL IMPLANTS AND IMPLANTED PATELLA RESURFACING. OVER 3 MONTHS AGO, ON (B)(6) 2021, THIS PATIENT HAD A LINER (LOT 184907 )SWAP DUE TO AN INFECTION THIS EVENT WASN'T REPORTED PREVIOUSLY DUE TO AGENT ERROR.

  Patient problems: Unspecified Infection

  MAUDE report 12630755 ↗
• InjurySep 3, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT'S KNEE WAS MEDIALLY UNSTABLE. THE SURGEON DECIDED TO REVISED ALL THE IMPLANTS TO A GMK HINGE SYSTEM 2 YEARS AND 1 MONTH AFTER PRIMARY.

  Patient problems: Joint Laxity

  MAUDE report 12419961 ↗
• InjuryJul 26, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY 4 MONTHS AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12224563 ↗
• InjuryOct 22, 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, REMOVED ALL COMPONENTS, AND IMPLANTED A GMK-SPHERE FEMUR AND INSERT TO ACT AS A SPACER 4 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10718022 ↗
• InjurySep 3, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FLEXION CONTRACTURE 2 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE FLEXION CONTRACTURE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10486975 ↗
• InjurySep 2, 2020Inadequacy of Device Shape and/or Size; Unstable; Noise, Audible

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF A CLICKING NOISE AND INSTABILITY OF THE KNEE. THE SURGEON REVISED THE 10MM POLY WITH A 13MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN AND THE SURGEON TOOK POST-OP X-RAYS. THE SURGEON DECIDED TO REVISE THE PATIENT'S FEMORAL COMPONENT ((B)(6) 2020), TIBIAL TRAY, AND INSERT DUE TO A MISMATCHED FLEXION EXTENSION AND REMOVED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482597 ↗
• InjuryAug 28, 2020Appropriate Device Problem Term/Code Not Available

  PATIENT COMPLAINTS OF KNEE PAIN. THE KNEE IS INFECTED. HE ATTENDED STEROID INJECTION. THE PATIENT HAS BEEN REVISED DUE TO INFECTION 6 MONTHS AFTER PRIMARY.

  Patient problems: Unspecified Infection

  MAUDE report 10464400 ↗
• InjuryFeb 28, 2020Loose or Intermittent Connection

  LOOSENING OF THE TIBIAL PLATE (NO INFECTION). ALL DEVICES WERE REVISED AND A GMK-REVISION SYSTEM WAS IMPLANTED ALMOST 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9769299 ↗
• InjurySep 5, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED THE SPHERE FEMUR CEMENTED RIGHT S5, GMK TIBIAL TRAY CEMENTED RIGHT S4, GMK SPHERE INSERT FLEX RIGHT 10MM S4, AND PATELLA RESURFACING S2. THE SURGEON IMPLANTED MEDACTA FULL-PE COMPONENTS WITH ANTIBIOTIC CEMENT TO ACT AS A TEMPORARY SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8964872 ↗
• InjuryJul 29, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 11 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED A FEMORAL COMPONENT, TIBIAL INSERT AND CEMENT SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8835136 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 11 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL HARDWARE. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8164771 ↗