GMK Sphere Total Knee System 02.12.E0410FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07630971261754), received between Mar 22, 2023 and Aug 11, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (19 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Device Appears to Trigger Rejection

  At about 11 month from the primary, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the Flex4L - 10mm insert to a same size insert. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50209597 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  At about 1 year and 4 months fro the primary, the patient came in reporting instability due to laxity and the cause of the laxity is unknown. The surgeon revised the GMK-SPHERE Tibial Insert from 10 mm to 13 mm to give the patient more stability. The surgery was completed successfully.

  Patient problems: Joint Laxity

  MAUDE report 50114136 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. AT ABOUT 11 MONTHS FROM PRIMARY SURGERY THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 10MM TO A GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 12MM FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25763517 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 10MM FLEX 4L INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25632983 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO FAILING COMPETITOR`S SUTURES IN QUAD WHICH RESULTED IN PATELLA TRACKING ISSUES. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON ADDRESSED THE SUTURES, PERFORMED A WASHOUT AND REVISED THE FLEX 4L - 10MM INSERT TO A FLEX 4L - 11MM INSERT TO IMPROVE THE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25528754 ↗
• InjuryMay 26, 2026Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN.THE SURGEON PERFORMED SURGICAL WASHOUT AND DEBRIDEMENT, WITH EXCHANGE OF THE INSERT TO ANOTHER INSERT OF THE SAME SIZE.THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25275480 ↗
• InjuryMay 22, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING DRAINAGE AT THE INCISION SITE OF THE PRIMARY AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED AN I&D OF THE JOINT AND REVISED THE INSERT WITH ANOTHER ONE OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25253491 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING STIFFNESS AND LIMITED RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED SCAR EXCISIONS AND REVISED THE 10MM INSERT TO AN 11MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 25039781 ↗
• InjuryApr 30, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER 12 DAYS FROM PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25039778 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON REVISED THE TIBIAL INSERT (FROM 10MMTO 12MM) TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24871677 ↗
• InjuryMar 3, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 1 MONTH POST-PRIMARY DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND THEN REVISED THE 10MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24494906 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER FROM 10MM TO 14MM TO ADDRESS THE ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24454900 ↗
• InjuryFeb 18, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON IS PERFORMING THE DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) TECHNIQUE WITH THE LEFT KNEE. THE SURGEON REVISED THE INSERT TO AN INSERT OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24376307 ↗
• InjuryFeb 12, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24321118 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE PRIAMARY, THE PATIENT CAME IN PRESENTING DRAINAGE FROM THE PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY EXCHANGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24208590 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT ONE 1 AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE INSERT FROM 10MM TO 13MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24208579 ↗
• InjuryJan 15, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24078372 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON UPSIZED THE LINER (10 TO 17MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23836922 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23510663 ↗
• InjuryOct 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ABOUT ONE MONTH POST-PRIMARY, THE PATIENT PRESENTED WITH SIGNS OF INFECTION OF UNKNOWN CAUSE. THE SURGEON OBSERVED NO DAMAGE OR LOOSENING OF ANY IMPLANTS. THE SURGEON PERFORMED AN INCISION AND DRAINAGE, AND ALSO REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23349014 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS FROM PRIAMARY PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION FROM UNKNOWN CAUSES. WASHOUT OF KNEE WAS COMPLETED AND CHANGE OF TIBIAL INSERT WAS PERFORMED. SURGEON SACRIFICED PCL DURING THE WASHOUT (DAIR), CONSEQUENTLY IMPLANTED DEVICE WAS A THICKER (14MM) NON-CRUCIATE RETAINING LINER.

  Patient problems: Medical device site infection

  MAUDE report 22369026 ↗
• InjuryJun 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22282503 ↗
• InjuryMay 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS. MEDICAL MANIPULATION UNDER ANAESTHESIA HAS BEEN PERFORMED IN ORDER TO RESTORE THE JOINT MOBILITY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21950432 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE INSERT TO GIVE THE PATIENT MORE STABILITY (10MM TO 14MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21933170 ↗
• InjuryMar 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND INSERT (10 TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 21595456 ↗