RINGLOC BI-POLAR HIP SYSTEM 11-165226Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304209732), received between Nov 24, 2021 and Sep 1, 2026 — classified as 1 death, 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543845 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that the locking ring of a bipolar implant came out of the groove. There was no patient impact. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475233 ↗
• MalfunctionAug 26, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452924 ↗
• MalfunctionFeb 23, 2026Fracture

  IT WAS REPORTED THAT THE O-RING WAS LOOSE AND BROKEN, WHICH PREVENTED THE HEAD/POLY FROM SEATING WITHIN THE SHELL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414344 ↗
• MalfunctionDec 13, 2025Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797875 ↗
• DeathAug 28, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED DURING AN INITIAL HIP PROCEDURE THAT THERE WAS DIFFICULTY POSITIONING THE RINGLOC BI-POLAR AND HEAD TOGETHER. IT WAS THEN DISCOVERED THAT THE RING IN THE BI-POLAR WAS BENT. AN ADDITIONAL 52 BI-POLAR WAS OPENED, AND THE HEAD WAS REMOVED FROM THE POLYETHYLENE SO THE NEW IMPLANT COULD BE POSITIONED. THERE WAS A 5 (FIVE) MINUTE DELAY DURING THE SURGERY DUE TO THE ISSUE WITH THE BIPOLAR CUP. CEMENT WAS USED FOR THE STEM. SUBSEQUENTLY, AFTER CLOSING THE OPERATION, THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND PASSED AWAY APPROXIMATELY 30 (THIRTY) MINUTES LATER. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THERE IS NO EVIDENCE TO SUGGEST THAT DEVICE CONTRIBUTED TO THE REPORTED DEATH. THE PATIENT WAS 86 YEARS OLD, FRAIL, AND HAD MULTIPLE COMORBIDITIES. AN INVESTIGATION IS IN PROGRESS. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911080 ↗
• MalfunctionOct 29, 2024Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561530 ↗
• InjurySep 18, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

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

  Patient problems: Bone Fracture(s); Failure of Implant; Joint Dislocation; Pain

  MAUDE report 17764551 ↗
• MalfunctionJul 26, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE CUP WOULD NOT ASSEMBLE WITH THE LINER. THE SURGERY WAS COMPLETED WITH AN ALTERNATIVE DEVICE AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105837 ↗
• MalfunctionNov 24, 2021Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870088 ↗

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