LCS COMPLETE AOX 1294-18-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295024293), received between Apr 25, 2019 and Mar 22, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE, SURGEON ELECTED TO REMOVE ALL IMPLANTS AND PERFORM AN ANTIBIOTIC SPACER. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11544506 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON PLANNED FOR A RIGHT HIP REVISION OF A (B)(6) YRS OLD FEMALE. PATIENT HAD A P.F.C. CEMENTED HIP, A PFC CUP, PFC LINER, 28+0 HEAD AND 2 SCREWS. ALL REMOVED AND REPLACED WITH A REVISION. HAD WE BEEN ABLE TO SOURCE A REPLACEMENT PFC ACETABULAR LINER AND ALL 28 AND 32 PFC HEAD OPTIONS, THIS SURGERY WOULD HAVE TAKEN 30 MINUTES INSTEAD OF 4 HOURS. THE SURGEON WAS AWARE OF THE LIMITED AVAILABILITY AND HIS PLAN A IF EVERYTHING WENT WELL WAS JUST TO CHANGE THE PFC HEAD WITH A 32+0 OPTION (ONLY ONE AVAILABLE) AND A MULTI HOLE GRIPTION CUP WITH A 32 ALTRX LINER. HOWEVER, PATIENT WAS MORE UNSTABLE THAN EXPECTED SO THE SURGEON REMOVED THE STEM&CEMENT, REMOVED CUP, LINER, SCREWS AND HEAD. REPLACED WITH A STRYKER DM CUP AND A LONG CEMENTED EXETER.

  Patient problems: No Code Available

  MAUDE report 10756517 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, SWELLING AND INFECTION. THE INSERT AND PATELLA POLY WERE CHANGED DURING A WASHOUT FOR INFECTION. DOI: (B)(6) 2014. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9526012 ↗
• InjuryAug 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT NEEDED A LARGE INSERT. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8925296 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED KNEE. REMOVAL OF ALL IMPLANTS. NO EXTRA SURGICAL TIME NEEDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8550886 ↗