NA 2178-70-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295096726), received between Sep 6, 2017 and Jan 20, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE LEFT FOOT OF THE BALANCER WILL NOT THREAD IN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306560 ↗
• MalfunctionJul 29, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE BALANCER CALIBRATION DIALED ARE LOCKED [IE. WILL NOT SPIN]. THE DOCTOR WANTS THEM AT MILLIMETERS AND THEY ARE STUCK ON LCS NUMBERS. PLEASE SEND REPLACEMENT SOS TO WNC OFFICE. THE CUTTING BLOCK DRILL HOLE BOUND UP AND THE PIN IS COLD WELDED IN PLACE. PLEASE SEND THE REPLACEMENT SOS TO WNC OFFICE. NO ADDITIONAL INFORMATION ON EITHER. NO SURGICAL DELAY.

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

  MAUDE report 10339521 ↗
• MalfunctionNov 12, 2019Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COULD NOT TRUST THE VALUE OF THE KNEE BALANCER BECAUSE THE SURGEON FELT THAT THE TENSION OF THE BALANCER¿S SPRING WAS WEAK DURING THE TKA SURGERY FOR OA ON (B)(6) 2019. IN THE HOSPITAL, 4 BALANCERS WERE USED. THE BALANCERS HAD TO BE IMPROVED BECAUSE THE VALUES OF THE BALANCERS WERE VARIATION. THE SURGICAL DELAY AND THE PATIENT OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311676 ↗
• MalfunctionNov 12, 2019Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COULD NOT TRUST THE VALUE OF THE KNEE BALANCER BECAUSE THE SURGEON FELT THAT THE TENSION OF THE BALANCER¿S SPRING WAS WEAK DURING THE TKA SURGERY FOR OA ON (B)(6) 2019. IN THE HOSPITAL, 4 BALANCERS WERE USED. THE BALANCERS HAD TO BE IMPROVED BECAUSE THE VALUES OF THE BALANCERS WERE VARIATION. THE SURGICAL DELAY AND THE PATIENT OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311669 ↗
• MalfunctionNov 12, 2019Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COULD NOT TRUST THE VALUE OF THE KNEE BALANCER BECAUSE THE SURGEON FELT THAT THE TENSION OF THE BALANCER¿S SPRING WAS WEAK DURING THE TKA SURGERY FOR OA ON (B)(6), 2019. IN THE HOSPITAL, 4 BALANCERS WERE USED. THE BALANCERS HAD TO BE IMPROVED BECAUSE THE VALUES OF THE BALANCERS WERE VARIATION. THE SURGICAL DELAY AND THE PATIENT OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311665 ↗
• MalfunctionNov 12, 2019Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COULD NOT TRUST THE VALUE OF THE KNEE BALANCER BECAUSE THE SURGEON FELT THAT THE TENSION OF THE BALANCER¿S SPRING WAS WEAK DURING THE TKA SURGERY FOR OA ON (B)(4) 2019. IN THE HOSPITAL, 4 BALANCERS WERE USED. THE BALANCERS HAD TO BE IMPROVED BECAUSE THE VALUES OF THE BALANCERS WERE VARIATION. THE SURGICAL DELAY AND THE PATIENT OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311659 ↗
• MalfunctionSep 13, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT 4 SIGMA KNEE BALANCERS WERE RETURNED TO THE MTO GROUP TO HAVE SPRING RATES MEASURED. UPON EVALUATION, TWO OF THE FOUR BALANCERS WERE FOUND TO BE DEFECTIVE. SPECIFICALLY, ONE EXHIBITED GALLING ON ONE SIDE OF THE TELESCOPING FEATURE AND WOULD NOT MOVE FREELY UNDER LOAD. THE SECOND ONE APPEARED TO HAVE THE PRE-TENSIONED NUT PARTIALLY UNSCREWED. THIS ELIMINATED THE BALANCE BETWEEN THE PADDLES. AS THE DEVICE IS NO LONGER AVAILABLE, BOTH DEFECTIVE BALANCERS WERE SENT TO THE (B)(4) BUT NEITHER OF THE DEVICES WERE REPAIRABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9028060 ↗
• MalfunctionSep 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 4 SIGMA KNEE BALANCERS WERE RETURNED TO THE MTO GROUP TO HAVE SPRING RATES MEASURED. UPON EVALUATION, TWO OF THE FOUR BALANCERS WERE FOUND TO BE DEFECTIVE. SPECIFICALLY, ONE EXHIBITED GALLING ON ONE SIDE OF THE TELESCOPING FEATURE AND WOULD NOT MOVE FREELY UNDER LOAD. THE SECOND ONE APPEARED TO HAVE THE PRE-TENSIONED NUT PARTIALLY UNSCREWED. THIS ELIMINATED THE BALANCE BETWEEN THE PADDLES. AS THE DEVICE IS NO LONGER AVAILABLE, BOTH DEFECTIVE BALANCERS WERE SENT TO THE (B)(4) BUT NEITHER OF THE DEVICES WERE REPAIRABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9028013 ↗
• MalfunctionJun 14, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE INSTRUMENT 217870000 WAS PURCHASED BY ACCOUNT IN JANUARY 2018 AND USED ONLY 10-12 TIMES. VERY SMALL SCREWS ARE BACKING OUT OF THE INSTRUMENT AND ARE LOST. TENSION WINDOW ADJUSTMENT DOES NOT ROTATE ANY LONGER. THIS IS THEIR 4TH TENSIONER AND THE OTHER 3 HAVE LASTED OVER 10-15 YEARS. THEIR NEW ONE FALLS APART IN 3 MONTHS. PRODUCT NEEDS TO BE REPLACED OR REPAIRED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601256 ↗
• MalfunctionSep 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE PADDLE DID NOT OPEN PROPERLY. INVESTIGATION METHOD: THE COMPLAINT SAMPLE CONSISTED OF (3) 217870000 INDEPENDENT BALANCER, LOT CODES: NB110243, NB110243, AND NB110243. INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE PADDLE DID NOT OPEN PROPERLY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6846378 ↗
• MalfunctionSep 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE PADDLE DID NOT OPEN PROPERLY. / INVESTIGATION METHOD: THE COMPLAINT SAMPLE CONSISTED OF (3) 217870000 INDEPENDENT BALANCER, LOT CODES, NB110243, NB110243, AND NB110243. / INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE PADDLE DID NOT OPEN PROPERLY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6846364 ↗
• MalfunctionSep 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PADDLE DID NOT OPEN PROPERLY.

  Patient problems: No Information

  MAUDE report 6846345 ↗