CORAIL L20106Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295257998), received between Apr 18, 2018 and Oct 26, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K042992, K070554, K192946); they may or may not involve this specific model.

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.

• InjuryOct 26, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. FEMORAL STEM WAS SLIGHTLY LOOSE AND REMOVED. REVISED WITH A BIOMET TAPER LOC STEM. DOI: UNKNOWN (APPROXIMATELY 11 YEARS AGO). DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10734084 ↗
• InjuryApr 18, 2018Loss of Osseointegration; Loss of Osseointegration

  HIP REVISION - (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2017. REASON FOR REVISION: PAIN, BONE SCAN INDICATES IMPLANT LOOSE. PATIENT FELL 6 MONTHS FOLLOWING SURGERY, PATIENT DEVELOPED PAIN IMMEDIATE POST FALL. INFECTION WAS RULED OUT AS CAUSE OF PAIN FOLLOWED BY BONE SCAN 6 MONTHS POST FALL. SURGEON FELT STEM WAS LOOSE AND WAS REMOVED. REPLACED WITH A CEMENTED STEM AND NEW HEAD ACETABULAR COMPONENTS WERE LEFT INSTITUTE. PATIENT ACTIVITY LEVELS - MODERATE ACTIVITY STILL WALKING WITH AID OF A WALKING STICK. FEMALE PATIENT INITIALS (B)(6). DOI: (B)(6) 2017; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Fall; Inadequate Osseointegration; Not Applicable; Pain; Unspecified Infection

  MAUDE report 7439717 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042992, K070554, K192946. One submission often covers many models, so check the product and lot details in each record.

• Z-2521-2018 · Jun 21, 2018 · Terminated
  CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511