RINGLOC BI-POLAR HIP SYSTEM 11-165232Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00880304001800), received between Feb 24, 2022 and Mar 14, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607384 ↗
• InjuryNov 5, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO MULTIPLE HEMIARTHROPLASTY DISLOCATIONS. DURING THE PROCEDURE, THE HEAD WAS FOUND TO BE OUT OF THE SHELL AND LINER CONSTRUCT. THE STEM WAS RETAINED AND OTHER IMPLANTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 20608725 ↗
• InjuryOct 7, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT DISLOCATED APPROXIMATELY 1 WEEK LATER. A CLOSED REDUCTION WAS PERFORMED TO FIX THE DISLOCATION; HOWEVER, IT WAS UNSUCCESSFUL. DURING THE CLOSED REDUCTION, THE CUP AND LINER DISASSEMBLED. A REVISION OCCURRED IMMEDIATELY FOLLOWING THE CLOSED REDUCTION. ALL ORIGINAL DEVICES REMAIN IMPLANTED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 20384116 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT HIP CLOSED REDUCTION ONE DAY POST IMPLANTATION DUE TO A DISLOCATION. THEN, THE PATIENT UNDERWENT ANOTHER CLOSED REDUCTION APPROXIMATELY SEVEN DAYS POST IMPLANTATION DUE TO A DISLOCATION. THIS REDUCTION, HOWEVER, WAS UNSUCCESSFUL. APPROXIMATELY NINE DAYS POST IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO A DISLOCATION. THE SHELL, LINER, AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 20383753 ↗
• InjuryAug 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP HEMI ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS CONVERTED TO TOTAL HIP ARTHROPLASTY APPROXIMATELY 2 MONTHS LATER DUE TO DISLOCATION. DURING THE REVISION IT WAS NOTED THAT THE PATIENT MOST LIKELY DISLOCATED MANY WEEKS PRIOR TO THE REVISION. ALL IMPLANTS WERE REPLACED WITHOUT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19990666 ↗
• InjuryMay 2, 2023Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL AND EXPERIENCED A DISLOCATION AFTER A BIPOLAR HIP PROCEDURE. THE SURGEON TRIED TO REDUCE BUT WAS UNABLE TO. IT WAS THEN FOUND THAT THE HEAD HAD SEPARATED FORM THE LINER AND BIPOLAR. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A WEEK LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Failure of Implant; Fall; Joint Dislocation; Muscle/Tendon Damage; Osteopenia/ Osteoporosis; Pain; Swelling/ Edema

  MAUDE report 16854717 ↗
• InjuryMar 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP PROCEDURE THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY TWO (2) WEEKS LATER. THE PATIENT WAS REVISED DUE TO DISLOCATION FROM FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16477601 ↗
• MalfunctionFeb 24, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE BIPOLAR LINER WOULD NOT FULLY SEAT INTO THE BIPOLAR SHELL. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590996 ↗

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