RINGLOC BI-POLAR HIP SYSTEM 11-165218Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304209688), received between Aug 11, 2022 and Jul 28, 2026 — classified as 2 deaths, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 17, 2020Class IITerminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2145-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent a revision approximately 3 days post-implantation due to dislocation. A patient was involved requiring revision surgery. Attempts have been made and no further information has been provided.

  Patient problems: Joint Dislocation

  MAUDE report 50053616 ↗
• DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Stroke/CVA

  MAUDE report 24664439 ↗
• DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Cardiac Arrest

  MAUDE report 24662330 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212432 ↗
• MalfunctionJan 28, 2026Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INNER BI-POLAR RING BECAME LOOSE, MAKING IT IMPOSSIBLE TO ASSEMBLE WITH THE LINER. THE PROCEDURE WAS COMPLETED USING A NEW RINGLOC BI-POLAR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199160 ↗
• MalfunctionJul 28, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SHELL WOULD NOT SNAP IN OVER THE LINER. 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 22636756 ↗
• MalfunctionJun 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO TWIST AND PUSH THE LINER INTO THE CUP, THEY WOULD NOT MATE. IT WAS FOUND THAT THE LOCKING RING WAS NOT IN THE CORRECT POSITION. 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 22123879 ↗
• MalfunctionApr 8, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED WHILE BUILDING THE CONSTRUCT, THE SHELL COULD NOT BE FIT OVER THE LINER. UPON EXAMINATION, THE INNER RING OF THE SHELL APPEARED BENT. THE IMPLANT WAS NOT EXAMINED BEFORE THE PROCEDURE TO CHECK FOR DAMAGE. THERE WAS NO PART AVAILABLE OF THE SAME SIZE, BUT THE SURGEON WAS COMFORTABLE DOWNSIZING A MILLIMETER. 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 21796635 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 10 DAYS POST IMPLANTATION DUE TO INFECTION. THE BIPOLAR CUP AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 15210998 ↗

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