RINGLOC BI-POLAR HIP SYSTEM 11-165224Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304005372), received between Mar 15, 2021 and Feb 26, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE LOCKING RING MECHANISM IN THE BIPOLAR PLASTIC WAS BENT AND NOT ENGAGING WITH THE HEAD CAUSING THE HEAD TO SLIP OUT. NO PATIENT HARM OR IMPACT REPORTED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457866 ↗
• InjuryJan 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION AT THE SITE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 21211253 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Material Twisted/Bent

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115450 ↗
• InjuryOct 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 2 MONTHS POST IMPLANTATION DUE TO DUE TO RECURRENT DISLOCATION. THE SURGEON INITIALLY ATTEMPTED A CLOSED REDUCTION 14 DAYS POST OP HOWEVER DISASSEMBLY OCCURRED. THE SURGEONS CONNECTED ALL COMPONENTS OF THE DISASSEMBLED RINGLOC WITHOUT THE IMPLANTATION OF ANY NEW ITEMS. AFTER THE SECOND DISLOCATION AND ATTEMPT AT CLOSED REDUCTION AGAIN, DISASSEMBLY AGAIN OCCURRED RESULTING IN THE SURGEON DECIDING TO REPLACE THE RINGLOC BIPOLAR. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 20545362 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECEIVED ADDITIONAL INFORMATION DOES NOT CHANGE THE FINAL CONCLUSIONS OF PREVIOUS INVESTIGATION.

  Patient problems: Unspecified Infection

  MAUDE report 11515635 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 11515626 ↗
• InjuryMar 15, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CASE TOOK PLACE, IT WAS A PARTIAL HIP DUE TO A FEMORAL NECK FRACTURE. EVERYTHING WENT AS PLANNED AND THE CASE WAS A SUCCESS. THREE WEEKS LATER, THE PATIENT WAS BROUGHT BACK DUE TO AN INFECTION. THE SURGEON WASHED OUT THE INFECTED HIP AND REPLACED THE FEMORAL HEAD WITH A NEW IMPLANT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 11483379 ↗

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