RINGLOC BI-POLAR HIP SYSTEM 11-165214Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of RINGLOC BI-POLAR HIP SYSTEM (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 1
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304209657), received between Sep 26, 2024 and Jun 1, 2026 — classified as 1 death, 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).
4 other recalls cover devices cleared under the same FDA submission (K051569, K833175); they may or may not involve this specific model.
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
- Device Dislodged or Dislocated5
- Difficult to Insert3
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- Joint Dislocation5
- No Clinical Signs, Symptoms or Conditions3
- Fall2
- Dementia1
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Difficult to Insert; Material Twisted/Bent
IT WAS REPORTED THAT DURING THE PROCEDURE; THE HEAD WAS INSERTED INTO THE LINER. WHEN TRYING TO INSERT THE LINER INTO THE SHELL, IT WOULD NOT INSERT AND THE LOCKING RING APPEARED TWISTED. 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 25347785 ↗DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST RIGHT HIP IMPLANTATION, THE PATIENT PASSED AWAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24662073 ↗InjuryNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO DISLOCATION AFTER FALLING. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Fall; Joint Dislocation
MAUDE report 23617961 ↗InjuryOct 23, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: Dementia; Fall; Joint Dislocation
MAUDE report 23373900 ↗InjuryOct 15, 2025Difficult to Insert; Difficult to Insert
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278102 ↗InjuryMar 11, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE CUP WON'T ASSEMBLE DUE TO THE RING BEING BENT. THE PROCEDURE WAS COMPLETED USING A NEW CUP. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21576720 ↗InjuryMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT FELL AND UNDERWENT A HIP REVISION DUE TO DISLOCATION. THE DOCTOR INITIALLY CHOSE A CLOSED REDUCTION, BUT THEN THE CUP AND HEAD SEPARATED AND THE COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 21546249 ↗InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THREE DAYS POST IMPLANTATION DUE TO A DISLOCATION. THE SHELL AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 20456301 ↗InjurySep 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 20310920 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051569, K833175. One submission often covers many models, so check the product and lot details in each record.
- Z-2179-2024 · May 17, 2024 · Open, ClassifiedRingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
- Z-0628-2021 · Nov 25, 2020 · TerminatedRINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phospha
- Z-0097-2021 · Sep 3, 2020 · Terminated(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 008803045687
- Z-1860-2017 · Feb 17, 2017 · Terminatedvarious polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constr
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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