RINGLOC BI-POLAR HIP SYSTEM 11-165212Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304209640), received between Jun 23, 2020 and Mar 23, 2026 — classified as 1 death, 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE 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 24662485 ↗
• MalfunctionJan 14, 2026Positioning Failure

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067556 ↗
• MalfunctionJan 6, 2026Positioning Failure; Difficult to Insert

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973123 ↗
• MalfunctionMar 28, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE SHELL WOULD NOT SLIDE OVER THE LINER. THE RING WAS FOUND BENT ON THE SHELL. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719575 ↗
• MalfunctionOct 8, 2024Fracture; Difficult to Insert; Material Twisted/Bent; Fracture; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE SHELL DID NOT ASSEMBLE PROPERLY AND A PART OF IT WAS BROKEN. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395305 ↗
• MalfunctionMar 18, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE IMPLANTS WERE INSTALLED, THE TWO CUPS WOULD NOT REMAIN ENGAGED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920926 ↗
• MalfunctionJan 16, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON ATTEMPTED TO PLACE THE LINER IN THE SHELL AND THE LOCKING RING WAS FOUND BENT. IT IS UNCLEAR WHEN EXACTLY THE LOCKING RING WAS BENT. THE SURGERY WAS COMPLETED WITH A DIFFERENT DEVICE. 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 18519871 ↗
• MalfunctionJun 29, 2023Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225515 ↗
• MalfunctionApr 25, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE BIPOLAR LINER WOULD NOT SEAT IN THE CUP SMOOTHLY. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194246 ↗
• InjuryFeb 28, 2022Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth; Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 2 MONTHS¿ POST IMPLANTATION DUE TO IMPLANT LOOSENING. DURING THE PROCEDURE ALL IMPLANTS WERE REMOVED INCLUDING A 44 RINGLOC BIPOLAR WITH A 44 +5 LINER WHICH WERE OFF-LABEL USE, SURGEON WAS AWARE. THE PATIENT NOW ONLY HAS CEMENT IN THE HIP AREA. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13618632 ↗
• MalfunctionApr 9, 2021Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640462 ↗
• MalfunctionJun 23, 2020Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10186983 ↗

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, Classified
  RingLoc 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 · Terminated
  RINGLOC 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 · Terminated
  various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constr