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RINGLOC BI-POLAR HIP SYSTEM 11-165230Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of RINGLOC BI-POLAR HIP SYSTEM (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304209756), received between Jun 14, 2023 and Mar 25, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1
  • Difficult to Insert1
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Failure of Implant1
  • Joint Dislocation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 25, 2026Difficult to Insert

    IT WAS REPORTED THAT THE BI-POLAR SHELL WOULD NOT SEAT INTO THE LINER AND HEAD CONSTRUCT. NO PATIENT HARM OR IMPACT REPORTED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24687852 ↗
  • MalfunctionJan 28, 2026Fracture

    IT WAS REPORTED WHILE ATTEMPTING TO PUT THE SIZE 53 RINGLOC BIPOLAR HEAD TOGETHER, THE PLASTIC LINER WITH 28MM NECK IN IT, WOULD NOT INSERT INTO THE MEDAL OUTER SHELL. IT WAS DISCOVERED THAT THE RING IN THE METAL HEAD WAS BROKEN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24200102 ↗
  • InjuryJun 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Patient problems: Failure of Implant; Joint Dislocation

    MAUDE report 17127580 ↗

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

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

Sources and updates

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