RINGLOC HIP SYSTEM EP-105790Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304466821), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
- Material Erosion1
Patient problems
- Failure of Implant1
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2023Material Erosion; Fracture; Material Erosion; Fracture
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY 4 YEARS LATER. DURING THE REVISION SOME METALLOSIS WAS NOTED WITHIN THE SOFT TISSUES, ACETABULAR LINER WAS FRAGMENTED, THE HEAD HAD SIGNIFICANT METAL LIKE WEAR, AND ONE SCREW WAS PROMINENT OF 0.5MM WITHIN THE ACETABULUM. THE HEAD, LINER, TAPER, AND RINGLOC WERE REPLACED AND THE PROMINENT SCREW WAS REMOVED. THE JOINT WAS IRRIGATED WITHOUT DEBRIDEMENT AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 17165582 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.