Knee Instruments 11.01001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030877414), received between Aug 25, 2017 and Jun 18, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2019Break

  FEMORAL IMPACTOR EXTRACTOR BREAKAGE (INSTRUMENT CENTRAL BODY) OCCURRED WHILE THE SURGEON WAS IMPACTING THE FEMUR. THERE WAS NO DELAY, AND ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707236 ↗
• MalfunctionMar 22, 2019Material Fragmentation; Material Fragmentation

  DURING PRIMARY TKA THE TIP OF THE IMPACTOR HANDLE BROKE AND IT WAS IMPOSSIBLE TO GET THE TRIAL KEEL OUT OF THE PATIENT. AFTER SOME ATTEMPTS A METAL CHISEL WAS USED TO GET IT OUT. ALSO IN THIS CASE IT WAS IMPOSSIBLE TO REMOVE THE TRIAL KEEL, THAT BROKE OFF, TOO. THEY WERE FORCED TO OPEN A NEW GMK EFFICIENCY KIT AND USE THE NEW IMPACTOR HANDLE SUCCESSFULLY. THE BONE WAS VERY HARD DUE TO A TIBIA OSTEOTOMY CARRIED OUT SOME YEARS AGO BEFORE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8443861 ↗
• MalfunctionMar 8, 2019Material Fragmentation; Material Fragmentation

  DURING A MYKNEE EFFICIENCY CASE, WHILST THE SURGEON WAS IMPACTING THE DEFINITIVE FEMORAL COMPONENT, THE EFFICIENCY FEMORAL CLAMP BROKE INTO MULTIPLE PIECES. A FEW SMALL SHARDS OF PLASTIC WENT INTO THE WOUND AND WERE RETRIEVED BY THE SURGEON, WITH ABOUT 2 MINUTES OF DELAY. IT IS UNKNOWN IF ALL PIECES WERE RETRIEVED, BUT THE SURGEON IS PRETTY SURE HE GOT EVERYTHING. THE FEMORAL CEMENT IMPACTOR WAS USED TO FINISH IMPLANTING THE FEMORAL COMPONENT.

  Patient problems: No Code Available

  MAUDE report 8403058 ↗
• MalfunctionMar 1, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY KNEE SURGERY, THE FEMORAL IMPACTOR BROKE WHILE IMPACTING THE FEMUR. A FRAGMENT FELL INTO THE PATIENT BUT THE SURGEON WAS ABLE TO RECOVER IT. THE SURGEON SUCCESSFULLY IMPACTED THE FEMUR WITHOUT HAVING TO SWAP TO A DIFFERENT IMPACTOR AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8381779 ↗
• MalfunctionMar 22, 2018Break; Break

  DURING THE TRIAL REDUCTION WITH TRIAL COMPONENTS IN PLACE, WHILE ADJUSTING THE TIBIAL TRAY POSITION FOR BEST COVERAGE, THE TIBIAL HANDLE SUDDENLY DISASSEMBLED FROM THE TRAY. THE TIBIAL OFFSET HANDLE WAS BROKEN.

  Patient problems: No Information

  MAUDE report 7361000 ↗
• MalfunctionFeb 20, 2018Break; Break

  THE SLIT OF 4IN1 CUTTING GUIDE WAS SHAVED DURING FEMORAL BONE CUT WITH 1.19 MM BONE SAW BLADE. THE PLASTIC DEBRIS DETACHED FROM THE GUIDE WERE REMOVED THROUGH A WASH OUT.

  Patient problems: No Information

  MAUDE report 7282357 ↗
• MalfunctionSep 1, 2017Break; Break

  THE PATIENT HAD HARD SCLEROTIC BONE. THE SURGEON PREPARED TIBIA ACCORDINGLY. UPON RANGE OF MOTION, SURGEON DECIDED TO TAKE ADDITIONAL 2MM OF TIBIA. AFTER DOING SO, THE SURGEON PROCEEDED TO PLACE GMK-EFFICIENCY TIBIA PLATE BACK ON AND DID NOT REPREPARED THE TIBIA WITH METAL REAMER. THE SURGEON TAPPED THE GMK-EFFICIENCY TIBIAL CRUCIATE INTO PLACE. IT TOOK SEVERAL ATTEMPTS TO SEAT PROPERLY. UPON GOING THROUGH RANGE OF MOTION AND SURGEON SATISFACTION, THE SURGEON ATTEMPTED TO REMOVE THE GMK-EFFICIENCY TIBIAL PLATE AND CRUCIATE. FIRST ATTEMPT, DONE WITH A GMK-EFFICIENCY HANDLE FAILED, WITH PLASTIC ATTACHMENT PIECE FOR CRUCIATE BREAKING. THE SECOND ATTEMPT, DONE WITH NEW GMK-EFFICIENCY HANDLE FAILED, WITH PLASTIC ATTACHMENT PIECE FOR CRUCIATE BREAKING. THE SURGEON THEN USED OSTEOTOME TO LIFT THE PLATE AND CRUCIATE TOGETHER FROM THE TIBIA, LOOSENING THE CRUCIATE FROM THE TIBIA. PIECES WERE REMOVED. THE SURGEON PREPARED THE TIBIA WITH METAL REAMER AND GMK-EFFICIENCY CRUCIATE AGAIN AND PROCEEDED TO CEMENT COMPONENTS FOR THE TOTAL KNEE. THE DELAY WAS APPROXIMATELY 2-3 MINUTES. INSTRUMENTS ARE NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6837579 ↗
• MalfunctionAug 25, 2017Break; Break

  DURING THE PIN IMPACTION, THE PIN ADAPTER BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE METALLIC PIN ADAPTER AND THE METALLIC 4 IN 1 CUTTING GUIDE.

  Patient problems: No Information

  MAUDE report 6819966 ↗