LPS 1987-15-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295078814), received between Nov 10, 2017 and Nov 23, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT LPS DISTAL FEMORAL REPLACEMENT ON (B)(6) 2014. PATIENT THEN PRESENTED WITH A LOOSE DISTAL FEMORAL REPLACEMENT WHICH WAS REVISED TO ANOTHER DISTAL FEMORAL REPLACEMENT WITH CEMENTED STEM ON (B)(6) 2015 ((B)(6) HOSPITAL). (A PC WOULD HAVE BEEN SUBMITTED). PATIENT HAS AGAIN PRESENTED WITH A LOOSE DISTAL FEMORAL REPLACEMENT ALONG WITH PROXIMAL FEMORAL FRACTURES. A DECISION WAS MADE TO REMOVE THE DISTAL FEMORAL REPLACEMENT, LEAVE THE EXISTING MBT REVISION TRAY IN SITU AND REPLACE THE DISTAL FEMORAL REPLACEMENT WITH A TOTAL FEMORAL REPLACEMENT - DO TO LACK OF PROXIMAL BONE AND THE VIEW THAT CEMENTING IN ANOTHER DISTAL FEMUR WOULD RESULT IN FURTHER LOOSENING. ((B)(6) HOSPITAL, (B)(6) 2022).

  Patient problems: Limb Fracture

  MAUDE report 15852428 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF FEMORAL STEM AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 7017429 ↗