NA 2490-49-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295125891), received between Sep 24, 2018 and Oct 10, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Break; Break

  IT WAS REPORTED THAT ON THE LCS ALIGNMENT ANKLE CLAMP THE BLACK PLASTIC PIECE THAT CONNECTS WITH THE UPROD HAS BEEN SNAPPED. THERE WERE NO DELAYS TO THE SURGERY, AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23269485 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT THE EXTERNAL ALIGNMENT HANDLE ON THE LCS MILESTONE TIBIAL JIG IS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22463185 ↗
• MalfunctionMar 18, 2021Mechanical Jam; Mechanical Jam

  BROKEN AND WORN. TIBIAL JIG LEG CLAMP WHEEL IS LOCKED IN PLACE POST STERILIZATION. BROKEN STEINMAN PIN WHICH SNAPPED AT THE END IN THE PIN DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516396 ↗
• MalfunctionMar 15, 2021Mechanical Jam; Mechanical Jam

  BROKEN AND WORN LCS MILESTONE TIBIAL JIG. THE SILVER LOCKING KNOB ON THE ANKLE CLAMP WAS JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11487949 ↗
• MalfunctionFeb 11, 2021Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  WORN INSTRUMENTS IDENTIFIED BY STERILIZATION DEPARTMENT, ITEMS ARE NEW CONSIGNMENT SENT TO THE HOSPITAL. THE LOCKING WHEEL IS COLD WELDED, SO THIS ITEM CAN NOT BE USED. DID NOT OCCUR DURING SURGERY SO NO SURGEON WAS INVOLVED. THIS HAS BEEN REPORTED BY ONE OF THE HEALTHCARE WORKERS AT THE HOSPITAL WHO IS THE CONTACT IN THIS FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315742 ↗
• MalfunctionOct 7, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  BROKEN AND WORN LCS MILESTONE TIBIAL JIG BLACK UPROD. PRODUCT CODE 2490-46. LOT AYO597F AND BLACK UPROD. THE SILVER BARREL DOES NOT ENGAGE PROPERLY ON THE THREADS OF THE UPROD.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10642885 ↗
• MalfunctionMar 30, 2020Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Break; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  BROKEN AND WORN LCS EXTERNAL ALIGNMENT CLAMP REPORTED BY CSSD STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898318 ↗
• MalfunctionMar 12, 2020Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  BROKEN AND WORN TIBIAL JIG LCS. WOULD NOT EXTEND DURING SURGERY, LOCKING MECHANISM WAS JAMMED, 10 MINUTE DELAY WHILST ALTERNATIVE KIT SOURCED. PIN PULLER THE SPRING HAS WORN AND A NEW ONE IS REQUIRED.

  Patient problems: Not Applicable

  MAUDE report 9823908 ↗
• MalfunctionDec 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED IT WAS REVEALED AT THE TIME OF WASHING THE INSTRUMENTS POSTOPERATIVELY TKA ON (B)(6) 2019 THAT THE TIBIAL RESECTION GUIDE (P/N: 228701000) AND THE ANKLE CLAMP (P/N: 249049000) COULD NOT BE SEPARATED BECAUSE IT COULD NOT BE LOOSENED THE SCREW OF THE CONNECTION PART. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451768 ↗
• MalfunctionDec 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCREW PART OF THE ALIGN ANKLE CLAMP (P:N/ 249049000) BROKEN DURING TKA SURGERY FOR OA ON (B)(6) 2019. WHEN THE SURGEON TRIED TO FIX THE BONE TO CUT PROXIMAL TIBIAL BONE, THE SCREW PART OF THE CLAMP BROKE. THERE WAS NO ADVERSE EVENT TO THE PATIENT AND NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405689 ↗
• MalfunctionNov 26, 2019Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking; Device-Device Incompatibility; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TIBIAL UPROD WILL NOT SLIDE DOWN INTO THE CLIP. LOOKS LIKE METAL IMPEDING THE TUBE. A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9376108 ↗
• MalfunctionJun 25, 2019Break; Break

  TOTAL KNEE REPLACEMENT: (B)(6) HOSPITAL, PRIMARY IMPLANTED DATE: (B)(6) 2019. NOT A REVISION. CONSIGNMENT INSTRUMENT BROKEN NEEDING URGENT REPLACEMENT. INSTRUMENT IS IN EXCESS OF 25 YEARS OLD. INSTRUMENT WAS ABLE TO STILL WORK DESPITE BEING BROKEN. SPRING ATTACHED TO ANKLE CLAMP KEEPS FALLING OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730521 ↗
• MalfunctionApr 3, 2019Component Missing; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking; Component Missing; Device-Device Incompatibility; Material Deformation; Physical Resistance/Sticking

  ONE INSTRUMENT DID NOT PERFORM AS INTENDED DUE TO MISSING PART AND JAMMED SCREW. OTHER 2-PART INSTRUMENT DID NOT FIT TOGETHER. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480083 ↗
• MalfunctionMar 28, 2019Break; Break

  TIBIAL JIG IS BROKEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461557 ↗
• MalfunctionNov 19, 2018Mechanical Jam; Mechanical Jam

  THE LCS ANKLE CLAMP BLACK UP ROD, HAS THE SLEEVE STUCK IN PLACE. UNABLE TO INSERT AND SECURE THE PROXIMAL ROD THAT ATTACHES THE TIBIAL CUTTING BLOCK INTO THE ANKLE CLAMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086118 ↗
• MalfunctionSep 24, 2018Crack; Crack

  A CRACK HAS DEVELOPED IN AN LCS RP TRIAL INSERT FROM THE INSTRUMENT KIT. SPD DEPARTMENT IS UNABLE TO STERILIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902936 ↗