NA 1294-35-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295026013), received between Feb 15, 2022 and Mar 7, 2025 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTED LEFT DISTAL FEMORAL REPLACEMENT. REMOVED CERTAIN IMPLANTS AND PERFORMED WASHOUT AND I&D. REPLACED CERTAIN IMPLANTS ALONG WITH SOME ANTIBIOTIC CEMENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21549869 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). ON (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. THIS WAS CAPTURED IN (B)(4). ON (B)(6) 2014: THE EXTENSOR MECHANISM HAS ¿SLID PROXIMALLY¿ CAUSING BONE GRAFT TO COME LOOSE AND PATELLA TO RIDE HIGH PER RADIOGRAPHS IN REFERENCE TO HIS ALLOGRAFT RECONSTRUCTION WITH RESIDUAL ROM AND STRENGTH DEFICITS. NO SURGICAL INTERVENTION IS TO BE DONE. HE IS TO CONTINUE PHYSICAL THERAPY ONLY. THIS WAS CAPTURED IN (B)(4). EARLY (B)(6) 2014: THE PATIENT SUSTAINS A FALL DUE TO A SENSE OF

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13584012 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. DOI: (B)(6) 2014, DOE: (B)(6) 2014, AFFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13535253 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. DOE: (B)(6) 2014.

  Patient problems: Renal Failure

  MAUDE report 13535074 ↗