Knee Instruments 11.01002Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030882890), received between Nov 29, 2017 and Jan 8, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Fracture

  AT 6 WEEKS POST-OP X-RAYS SHOWED AN ARTIFACT IN THE POSTERIOR PART OF THE FEMUR. BASED ON THE IMAGES IT IS HYPOTHESIZED TO BE THE TIP OF THE CENTRAL BODY OF THE EFFICIENCY IMPACTOR/EXTRACTOR, BUT THIS CANNOT BE CONFIRMED. SURGICAL STAFF REPORTED THAT NO BREAKAGE WAS NOTICED DURING PRIMARY SURGERY. ACCORDING TO THE SURGEON THE PATIENT PRESENTS A NORMAL LEVEL OF PAIN, COMPATIBLE WITH 6 WEEKS FOLLOW-UP, AND NO REVISION IS CURRENTLY SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003049 ↗
• InjuryNov 22, 2021Break; Break

  WHEN THE SURGEON WAS IMPACTING THE TIBIAL KEEL PUNCH, IT WAS OBSERVED THAT THE IMPACTOR HANDLE BROKE. THE SURGEON SPENT 25-MINUTES REMOVING THE STUCK KEEL PUNCH FROM THE PROXIMAL TIBIA AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY. THE PATIENT HAD A HARD BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12852080 ↗
• MalfunctionSep 20, 2019Material Fragmentation; Material Fragmentation

  WHEN THE SURGEON IMPACTED THE TRIAL FEMORAL COMPONENT, BOTH ENGAGING PARTS OF FEMORAL IMPACTOR/EXTRACTOR 77.11.0063 WERE BROKEN. THE BROKEN DEVICE WAS DISCARDED AT THE HOSPITAL. NO PICTURE IS AVAILABLE. NO CRITICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9097730 ↗
• MalfunctionSep 13, 2019Break; Break

  DURING THE PRIMARY KNEE SURGERY, AND WHILE THE SURGEON WAS USING THE IMPACTOR HANDLE TO EXTRACT THE TRIAL TIBIA AND KEEL PUNCH, THE YELLOW PIECE ON THE HANDLE BROKE. THE SURGEON USED A NEW HANDLE AND THERE WAS A 5-MINUTE DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9030509 ↗
• MalfunctionSep 11, 2019Material Fragmentation; Material Fragmentation

  WHEN THE SURGEON IMPACT THE TRIAL FEMORAL COMPONENT, BOTH ENGAGING PARTS OF FEMORAL IMPACTOR/EXTRACTOR WERE BROKEN. BROKEN DEVICE WAS DISCARDED AT THE HOSPITAL. THE SURGERY FINISHED WITH THE FINAL IMPACTOR. NO CRITICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8987627 ↗
• MalfunctionAug 12, 2019Material Fragmentation; Material Fragmentation

  WHEN THE SURGEON IMPACTED THE TRIAL FEMORAL COMPONENT, BOTH ENGAGING PARTS OF FEMORAL IMPACTOR/EXTRACTOR BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883097 ↗
• MalfunctionJul 30, 2019Break; Break

  WHEN THE SURGEON IMPACTS THE TRIAL FEMORAL COMPONENT, THE FEMORAL IMPACTOR/EXTRACTOR CLAW BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8840208 ↗
• MalfunctionJun 18, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY KNEE SURGERY, THE GMK EFFICIENCY FEMUR IMPACTOR BROKE WHILE THE SURGEON WAS TRYING TO PLACE THE FEMORAL COMPONENT. NO FRAGMENTS FELL INTO THE PATIENT AND THE SURGEON WAS ABLE TO IMPACT THE IMPLANT WITH A METAL FEMORAL IMPACTOR. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707535 ↗
• MalfunctionJun 12, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY KNEE SURGERY AND WHILE IMPACTING THE FEMORAL COMPONENT, THE GMK EFFICIENCY FEMORAL IMPACTOR/EXTRACTOR BROKE AT THE CENTRAL PART. NO BROKEN FRAGMENTS FELL INTO THE PATIENT'S SURGICAL WOUND AND THERE WAS ONE MINUTE DELAY IN THE CASE. THE SURGEON SWAPPED TO CONVENTIONAL INSTRUMENTATION TO COMPLETE THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8691478 ↗
• MalfunctionJun 6, 2019Fracture; Fracture

  WHEN THE SURGEON IMPACTS THE TRIAL FEMORAL COMPONENT, TWO FEMORAL IMPACTOR BROKE (CENTRAL BODY). THE REASON FOR THE BREAKAGE IS THAT THE FORCE WAS APPLIED TO CORRECT THE FLEXION OF THE TRIAL FEMORAL COMPONENT. THE SURGERY WAS COMPLETED WITH ANOTHER COMPANY'S INSTRUMENT WHICH WAS STORED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8673856 ↗
• MalfunctionApr 15, 2019Material Fragmentation; Material Fragmentation

  GMK EFFICIENCY PIN PULLER BROKE AT HINGE POINT DURING OPERATION. SURGERY COMPLETED SUCCESSFULLY AND WITHOUT DELAY USING THE METAL PIN PULLER. NO PART FELL INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8514350 ↗
• MalfunctionMar 27, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY TKA AND WHILE ATTACHING THE FEMORAL COMPONENT TO THE FEMORAL EXTRACTOR TO AIDE IN CEMENTING, A PIECE OF THE FEMORAL EXTRACTOR BROKE OFF. NO FRAGMENTS FELL INTO THE PATIENT AND THE SURGEON ATTACHED THE FEMORAL COMPONENT TO THE FEMORAL IMPACTOR IN ORDER TO CEMENT THE IMPLANT. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8455412 ↗
• MalfunctionMar 20, 2019Material Fragmentation; Material Fragmentation

  DURING PRIMARY KNEE SURGERY AND WHILE ATTEMPTING TO REMOVE THE FEMORAL TRIAL, THE EFFICIENCY FEMORAL EXTRACTOR BROKE AND A FRAGMENT FELL INTO THE PATIENT. A SECOND EFFICIENCY FEMORAL EXTRACTOR WAS USED TO REMOVE THE FEMORAL TRIAL AND THE SURGEON WAS ABLE TO RECOVER THE BROKEN FRAGMENT THAT HAD FALLEN INTO THE PATIENT. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436665 ↗
• MalfunctionFeb 15, 2019Break

  DURING THE PRIMARY KNEE SURGERY, THE YELLOW TIP OF THE EFFICIENCY IMPACTOR HANDLE BROKE WHILE THE SURGEON WAS IMPACTING THE FEMORAL TRIAL. NO FRAGMENTS FELL INTO THE PATIENT AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343135 ↗
• MalfunctionOct 31, 2018Material Fragmentation; Material Fragmentation

  DURING SURGERY THE FEMORAL IMPACTOR CHIPPED WHILE TIGHTENING THE TRIAL PLASTIC FEMUR. THE SURGEON USED CONVENTIONAL INSTRUMENTATION TO COMPLETE THE SURGERY. NO FRAGMENTS FELL INTO THE PATIENT AND NO SIGNIFICANT DELAY WAS REPORTED. THE INSTRUMENT WAS THROWN AWAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8023974 ↗
• MalfunctionNov 29, 2017Break; Break

  THE IMPACTOR HANDLE TIP BROKE OFF IN THE KEEL PUNCH A SECONDARY INSTRUMENT WAS USED TO REMOVE THE KEEL PUNCH FROM THE PATIENT. THERE WAS A SHORT DELAY OF APPROXIMATELY 2 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7067356 ↗