CORAIL 3L92518Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295168836), received between Aug 3, 2017 and Dec 31, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Missing Information” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT DURING A RECENT PACKAGING INTEGRITY CONFERENCE, IT WAS IDENTIFIED THAT SIX ITEMS ARE WITHOUT TRACEABILITY AND NATIONALIZATION LABELS. IT WAS NOT POSSIBLE TO DETERMINE EXACTLY WHEN THE LABELS WERE LOST, BUT THEIR ABSENCE WAS DETECTED DURING THE VERIFICATION PROCESS. WHEN THESE PRODUCTS WERE RECEIVED IN STOCK, WITH THE RECEIPT NOTE INVOICE (FIRST ENTRY), THERE WAS NO CLAIM RECORD REGARDING THE LACK OF LABELS, WHICH LEADS US TO CONCLUDE THAT THE ITEMS WERE PROPERLY LABELED AT THE ENTRANCE.

  Patient problems: Insufficient Information

  MAUDE report 21048397 ↗
• MalfunctionDec 31, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT DURING A RECENT PACKAGING INTEGRITY CONFERENCE, IT WAS IDENTIFIED THAT SIX ITEMS ARE WITHOUT TRACEABILITY AND NATIONALIZATION LABELS. IT WAS NOT POSSIBLE TO DETERMINE EXACTLY WHEN THE LABELS WERE LOST, BUT THEIR ABSENCE WAS DETECTED DURING THE VERIFICATION PROCESS. WHEN THESE PRODUCTS WERE RECEIVED IN STOCK, WITH THE RECEIPT NOTE INVOICE (FIRST ENTRY), THERE WAS NO CLAIM RECORD REGARDING THE LACK OF LABELS, WHICH LEADS US TO CONCLUDE THAT THE ITEMS WERE PROPERLY LABELED AT THE ENTRANCE.

  Patient problems: Insufficient Information

  MAUDE report 21048389 ↗
• InjuryNov 4, 2022Migration; Migration

  IT WAS REPORTED THAT SURGEON NEEDED A LONGER STEM DUE TO SUBSIDENCE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15735092 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNSTABLE HIP. DOI: UNKNOWN. DOR: UNKNOWN. UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 13860086 ↗
• InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR INDEX/REVISION SURGERY; ASR XL; ASR RIGHT HIP; REASON FOR REVISION: UNKNOWN. DOI: (B)(6) 2006; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Test Result

  MAUDE report 9718828 ↗
• InjuryNov 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ASR REVISION. RIGHT HIP. ASR XL ACETABULAR SYSTEM. REASON FOR REVISION: HIGH METAL ION LEVELS, ACETABULAR OSTEOLYSIS OF RIGHT TROCHANTER.

  Patient problems: No Information

  MAUDE report 7032541 ↗
• InjurySep 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ASR REVISION, RIGHT HIP, ASR XL ACETABULAR SYSTEM, REASON FOR REVISION: PAIN, HIGH CHROMIUM LEVELS.

  Patient problems: Host-Tissue Reaction; Pain

  MAUDE report 6837325 ↗
• InjuryAug 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, REVISION NOTES STATED LARGE INTRA-ARTICULAR EFFUSION, INTRA-ARTICULAR METALLOSIS, MINIMAL BONE LOSS, LARGE INTRA-OSSEOUS SOLID BONE CYST. PATHOLOGY REPORT SHOWED IRREGULAR FIRM BROWN TISSUE. CLINICAL NOTES REPORTED PAIN, DISCOMFORT, SWELLING, INTERMITTENTLY LIMP, MINIMAL TENDERNESS, SERUM COBALT IS ABOVE 7PPB. PART AND LOT INFORMATION WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON: AUG 8, 2017.

  Patient problems: Discomfort; Pain

  MAUDE report 6766074 ↗