RINGLOC BI-POLAR HIP SYSTEM 11-165216Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304009080), received between Feb 11, 2022 and Jun 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Positioning Failure

  IT WAS REPORTED THAT A PRODUCT WAS OPENED IN SURGERY AND FOUND TO BE DEFECTIVE AND CRUSHED. THE ISSUE WAS IDENTIFIED INTRA-OPERATIVELY UPON OPENING THE DEVICE FOR USE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532171 ↗
• MalfunctionMay 18, 2026Difficult to Insert

  IT WAS REPORTED THAT THE CUP AND LINER IMPLANTS WOULD NOT ASSEMBLE CORRECTLY. 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 25201435 ↗
• MalfunctionOct 23, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING IMPLANTATION, THE BI-POLAR RING WAS OBSERVED TO BE DEFORMED, WHICH PREVENTED THE LINER FROM BEING PROPERLY ASSEMBLED INTO THE CUP. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367501 ↗
• MalfunctionApr 23, 2024Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT THE ATTEMPT WAS MADE TO INSERT THE SHELL ONTO THE LINER AND IT WAS REALIZED THAT THE SHELL HAD A BROKEN LOCKING RING ON THE INSIDE. 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 19165796 ↗
• MalfunctionFeb 11, 2022Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515078 ↗

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