LPS 1987-27-318Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295079606), received between Dec 21, 2018 and Jan 2, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE I&D WITH POLY EXCHANGE FOR WOUND DEHISCENCE AFTER A FALL. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23943779 ↗
• InjuryJul 1, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD ABRASION AT THE DISTAL END OF THE INLAY. PATIENT UNDERWENT REVISION OF THE LEFT KNEE AND REPLACEMENT OF THE INLAY COMPONENT WITH COUPLING MECHANISM. IT WAS FURTHER REPORTED THAT PATIENT HAD PRIMARY IMPLANTATION WITH UNKNOWN MANUFACTURER IMPLANTS. ON (B)(6) 2020 PATIENT HAD THE REVISION TO S-ROM AFTER TREATMENT OF INFECTION.

  Patient problems: Insufficient Information

  MAUDE report 22376730 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE IMPLANTATION DATE OF THE RIGHT KNEE WAS (B)(6) 2019.

  Patient problems: Edema; Erythema; Injury; No Code Available; Not Applicable; Pain

  MAUDE report 10283394 ↗
• MalfunctionDec 21, 2018Device Damaged Prior to Use; Separation Problem; Device Damaged Prior to Use; Separation Problem

  IT WAS REPORTED THAT A BRAND NEW MEDIUM SROM 18MM POLY WAS OPENED AND THE POLY WAS DISASSOCIATED FROM THE MEDAL HINGE. POLY WAS IN TWO PIECES AS WAS UNUSABLE. A SURGICAL DELAY OF 20 MINUTES WAS NOTED. DOE: (B)(6) 2018.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8189157 ↗