Arcos® Modular Revision Hip System 11-302138Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304474406), received between Jul 12, 2021 and Sep 23, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (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
- Adverse Event Without Identified Device or Use Problem1
- Migration1
- Migration or Expulsion of Device1
- Separation Problem1
Patient problems
- Pain2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE FOLLOWED BY A REVISION DUE TO INFECTION. DURING THE REVISION, A TROCHANTERIC FRACTURE WAS FOUND AND A LARGE PLATE AND BOLT WERE PLACED, ALONG WITH CERCLAGE CABLES FOR FIXATION. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND SWELLING APPROXIMATELY NINE (9) MONTHS LATER, UNDERWENT A PROCEDURE FOR POSSIBLE REMOVAL. DURING THE PROCEDURE, THE SCREW WAS FOUND COMPLETELY LOOSE, THE PLATE WAS WELL FIXED, AND A PROXIMAL CERCLAGE WAS BROKEN. THE BOLT WAS REMOVED AND THE PLATE WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema
MAUDE report 23125655 ↗InjurySep 9, 2025Migration; Separation Problem; Migration; Separation Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION DUE TO THE TROCHANTERIC BOLT BACKING OUT OF THE SCREW HOLE THAT IS USED TO SECURE THE TROCHANTERIC CLAW TO THE PROXIMAL BODY. IT HAS NOT BEEN CONFIRMED WHICH COMPONENTS WERE REVISED, BUT A SCREW WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information; Pain
MAUDE report 23004028 ↗InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 12149672 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices
- Arcos Modular Revision Hip System 11-301310Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall9 reports
- Arcos Modular Revision Hip System 11-301342Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall4 reports
- Tritanium 502-03-52DHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish39 reports
- V40 Head 6260-5-332Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish12 reports
- EXETER 0580-1-443Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- V40 Head 6260-9-032Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- Trident 509-02-56EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish10 reports
- Taperloc Complete Primary Femoral 51-104180Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish9 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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