ARCOS MODULAR REVISION SYSTEM 31-301301Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304490048), received between Nov 29, 2023 and Nov 29, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED BY THE SURGEON THAT THE TRIALS ARE NOT PROPERLY LOCKING ONTO THE STEM ANYMORE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226167 ↗
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
- V40 Head 6260-9-032Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- EXETER 0580-1-443Howmedica 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.