GMK 02.12.E001RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630971260979), received between Sep 19, 2022 and Nov 18, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIVE MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH ANTERIOR KNEE PAIN OF UNKNOWN ORIGIN. THE SURGEON REPORTED THAT THE PATIENT HAD A LOW PAIN TOLERANCE AND QUESTIONED WHETHER IT WAS A TRUE DISLOCATION, SUGGESTING THAT IT MIGHT HAVE BEEN A PATELLAR TILT, A MORE COMMON POSTOPERATIVE OCCURRENCE IN TKA CASES WHEN THE PATELLA HAS BEEN RESURFACED. A LATERAL RELEASE OF THE PATELLAR TENDON WAS PERFORMED, FOLLOWED BY A WASHOUT AND LINER REVISION AS PER STANDARD PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Implant Pain

  MAUDE report 23583094 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PATELLAR TRACKING ISSUES OF UNKNOWN CAUSE. THE SURGEON REVISED THE PATELLAR COMPONENT AND REPLACED THE LINER PER STANDARD PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23510645 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THE PATELLA WAS MISTRACKED. THE SURGEON REVISED THE PATELLA FROM AN S1 TO AN S3. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23347368 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s)

  MAUDE report 23070843 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PAIN DUE TO PATELLA TRACKING ISSUES OF UNKNOWN CAUSE. THE SURGEON REVISED THE FEMUR AND INSERT AND ADDED A LATERAL FEMORAL AUGMENT TO SHIFT THE KNEE INTO MORE VARUS, STABILIZING THE PATELLA.THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 22902798 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN, AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE PATELLA TO A THINNER PATELLA AND REMOVED MORE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22577498 ↗
• InjuryJan 31, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 MONTHS AFTER PRIMARY, 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 AN ANTIBIOTIC SPACER.

  Patient problems: Medical device site infection

  MAUDE report 18612968 ↗
• InjuryFeb 24, 2023Migration; Migration

  THE DAY AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED BECAUSE OF DISLOCATED PATELLA IMPLANT. THE DISLOCATION OCCURRED DURING POST-OP, IN EXTENSION PHASE WHEN PATIENT TRIED TO WALK. THE SURGEON REVISED INSERT AND FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. INSERT AND FEMUR REVISED TO SWITCH TO A REVISION SYSTEM, PATELLA IMPLANT NOT REVISED.

  Patient problems: Insufficient Information

  MAUDE report 16435235 ↗
• InjuryOct 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING LOOSENESS AFTER DISLOCATING THE PATELLA. THE SURGEON REVISED THE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L -10MM WITH A GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3L -14MM AND REPOSITIONED THE PATELLA WITH SOFT TISSUE REPAIR. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING LOOSENESS AFTER DISLOCATING THE PATELLA AGAIN. THE SURGEON DECIDE TO REVISE ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 15579655 ↗
• InjurySep 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATED PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A LATERAL RETINACULAR RELEASE AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15444689 ↗