Arcos Modular Revision Hip System 11-300918Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Arcos Modular Revision Hip System (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00880304474284), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Positioning Failure1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. DURING THE PROCEDURE, THERE WAS ISSUES WITH THE INSERTER. ATTEMPTS WERE MADE TO FIX THE PROXIMAL BODY TO THE DISTAL STEM IN A REAM-OVER TECHNIQUE. HOWEVER, IT WOULD NOT WORK DESPITE THE TECHNIQUE BEING UTILIZED. MULTIPLE ATTEMPTS WERE TRIED TO ASSEMBLE THE CORRECT INSTRUMENTATION TO NO AVAIL. THE SURGEON THEN ATTEMPTED TO FIX THE PROXIMAL BODY TO THE DISTAL STEM USING A BASTARDISED TECHNIQUE TO FIX THE STEM AND PROXIMAL BODY TOGETHER. THERE WAS A 25-MINUTE DELAY DURING SURGERY DUE TO INSTRUMENTATION NOT WORKING. AFTER THE CASE, IT WAS DETERMINED THAT THE GREY INSERTION HANDLE WAS DAMAGED AND BURRED AT THE INSERTION END WHICH DID NOT ALLOW THE ASSEMBLY ROD TO ENTER. THERE WAS NO DAMAGE NOTED TO THE INSTRUMENT PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE STEM OR PROXIMAL BODY IMPLANTS. THE FOLLOWING DAY, AN X-RAY SHOWED THAT THE STEM AND PROXIMAL BODY HAD A DUBIOUS COUPLING. IT WAS ALSO NOTED THAT THE PROXIMAL BODY WAS HUNG UP ON THE MEDIAL CALCAR AND WAS NOT SEATED IN THE PROXIMAL REAMED BONE. THE SURG
Patient problems: Failure of Implant
MAUDE report 20516179 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
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- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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