RINGLOC BI-POLAR HIP SYSTEM 11-165210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304005358), received between Mar 24, 2022 and Oct 9, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 20407136 ↗
• MalfunctionMar 21, 2024Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954137 ↗
• MalfunctionAug 30, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THE PLASTIC LINER WOULDN'T GO INTO THE METAL SHELL OF THE BIPOLAR. AFTER SEVERAL ATTEMPTS IT WAS DISCOVERED THAT THE METAL LOCKING RING WAS BENT AND OUTSIDE OF THE TRACK WHICH PREVENTED THE LINER FROM SEATING. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320872 ↗
• MalfunctionMar 24, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED WHEN OPENING THE BIPOLAR LINER PACKAGING; THE INTERIOR RIM OF THE BIPOLAR CUP WAS BENT IN, NOT ALLOWING THE IMPLANT TO BE USED. THERE WAS AN ATTEMPT TO PLACE THE METAL RIM BACK INTO POSITION AND SEAT THE LINER, BUT WAS UNSUCCESSFUL AS THE RIM WAS BENT ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13890004 ↗

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