SR MCP 5800-LG00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886385020983), received between Oct 12, 2021 and Nov 6, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 20616330 ↗
• InjuryJan 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS A LOOSE IMPLANT WHICH RESULTED IN A REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16103068 ↗
• InjuryOct 12, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THE PATIENT REQUIRED REVISION SURGERY DUE TO A WORN POLY AND DISLOCATED JOINT. THE ORIGINAL SURGERY WAS AT LEAST 10 YEARS PRIOR TO THE REVISION.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 12619097 ↗