RINGLOC BI-POLAR HIP SYSTEM 11-165236Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304209794), received between Nov 30, 2021 and Sep 10, 2026 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionSep 10, 2026Positioning Failure; Material Twisted/Bent

  It was reported that the locking ring was slightly bent inside bipolar head and would not allow poly to engage. There was no known impact or consequences to the patient. It was reported that no further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717722 ↗
• InjuryNov 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST-IMPLANTATION OF A HEMIARTHROPLASTY, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO MULTIPLE HIP DISLOCATIONS. DURING THE PROCEDURE, THERE WAS HEMATOMA AND BLOOD CLOT EVACUATION AND ENCOUNTERED SHREDDED REMNANTS OF THE SHORT EXTERNAL ROTATORS AND POSTERIOR CAPSULE WHICH HAD BEEN DAMAGED FROM MULTIPLE DISLOCATIONS. ALL COMPONENTS WERE REVISED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hematoma; Joint Dislocation; Muscle/Tendon Damage

  MAUDE report 20652150 ↗
• MalfunctionNov 30, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE IMPLANT WAS OPENED TO THE STERILE FIELD. THE SCRUB TECH WENT TO PLACE THE PLASTIC AND 28 METAL HEAD INSIDE THE 56MM CUP USING A TWO THUMB METHOD AND IT WOULD NOT ASSEMBLE. SHE PLACED THE 56MM CUP ON HER BACK TABLE AND TRIED USING HER PALM TO ENGAGE. ANOTHER CUP WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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 12895116 ↗

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