Arcos Modular Revision Hip System 11-300915Recalls & 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
- 5
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304480513), received between May 26, 2023 and Aug 1, 2024 — classified as 1 death, 4 injuries.
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. 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 Problem2
- Difficult to Insert1
- Fracture1
- Malposition of Device1
Patient problems
- Bone Fracture(s)2
- Failure of Implant1
- Hemorrhage/Blood Loss/Bleeding1
- Nerve Damage1
- Pain1
- Unequal Limb Length1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 19885634 ↗InjurySep 7, 2023Malposition of Device; Malposition of Device
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Unequal Limb Length
MAUDE report 17698670 ↗InjuryAug 7, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING THE PROCEDURE, THE STEM WOULD NOT SEAT PROPERLY. SUBSEQUENTLY, THE FEMUR WAS FRACTURED WHILE TRYING TO OBTAIN THE CORRECT PLACEMENT FOR THE STEM. ADDITIONALLY, THE SURGEON EXPERIENCED DIFFICULTY ASSEMBLING THE CUP AND LINER. A NEW LINER WAS OPENED. AND WAS ABLE TO BE SUCCESSFULLY ASSEMBLED TO THE SHELL. DUE TO ALL THESE ISSUES, THE SURGERY WAS DELAYED FOR ONE HOUR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 17470509 ↗DeathJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO WEEKS POST THE INITIAL PROCEDURE BECAUSE A PROPER FIT WAS NOT ABLE TO BE OBTAIN BETWEEN THE LINER AND THE SHELL DURING THE INITIAL PROCEDURE. THERE WAS THIS DELAY BETWEEN THE TWO PROCEDURES DUE TO NEEDING TO OBTAIN COMPATIBLE BLOOD PRODUCTS FOR THE PATIENT. THE SURGERY ITSELF WAS ALSO PROLONGED DUE TO NUMEROUS COMPLICATIONS INCLUDING EXCESSIVE BLEEDING, INCORRECT COMPONENT POSITIONING, FEMUR FRACTURE, AND ADDITIONAL DIFFICULTY WITH IMPLANT PLACEMENT. ULTIMATELY, SATISFACTORY IMPLANTATION WAS ACHIEVED AND THE PROCEDURE CONCLUDED. HOWEVER, THE PATIENT IS REPORTED TO HAVE EXPIRED WITHIN 4 HOURS AFTER THE CONCLUSION OF THE PROCEDURE.
Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding
MAUDE report 17170133 ↗InjuryMay 26, 2023Adverse 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: Nerve Damage; Pain
MAUDE report 17011000 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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