RINGLOC BI-POLAR HIP SYSTEM 11-165228Recalls & 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
- 12
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304001930), received between Mar 1, 2021 and Sep 8, 2026 — classified as 1 death, 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (6 reports).
1 FDA recall record name this device's identifier.
3 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
Recalls naming this device
- Sep 3, 2020Class IITerminated
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
Z-0097-2021 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Difficult to Insert6
- Detachment of Device or Device Component4
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
- Device Dislodged or Dislocated1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Difficult to Insert
It was reported that the Ringloc BI-Polar cup couldn¿t be smoothly inserted into the inner track, which also prevents the liner from locking in properly. It was confirmed that no further information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670181 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RING ON THE CUP WAS COMPLETELY OUT OF THE CUP WHEN THEY OPENED IT. ANOTHER IMPLANT WAS OPENED TO COMPLETE THE CASE. 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 25176037 ↗DeathMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY THREE WEEKS AFTER A HEMIARTHROPLASTY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24525010 ↗MalfunctionSep 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963967 ↗MalfunctionMar 27, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE SHELL/LOCKING RING AND INNER LINER WOULD NOT ASSEMBLE TOGETHER. UPON INSPECTION, THE INNER RING LOOKED DEFORMED. THERE WAS NO DELAY OR IMPACT TO THE PATIENT. THERE IS NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21706725 ↗MalfunctionSep 19, 2024Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20262256 ↗MalfunctionJul 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RINGLOC LOCKING RING MECHANISM FAILED AS THE RING WAS FOUND NOT ATTACHED AFTER OPENING THE PACKAGING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19851100 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19690343 ↗MalfunctionJul 24, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORT THAT WHILE PUTTING TOGETHER THE BIPOLAR CUP, LINER AND HEAD, THE IMPLANTS WOULD NOT GO TOGETHER PROPERLY. NEW IMPLANTS HAD TO BE OPENED FOR THE PROCEDURE. 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 17381084 ↗MalfunctionFeb 27, 2023Difficult to Insert; Detachment of Device or Device Component; Material Deformation; Difficult to Insert; Detachment of Device or Device Component; Material Deformation
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16444473 ↗MalfunctionMay 20, 2021Difficult 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 11855164 ↗InjuryMar 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SURGEON CONTRIBUTES THE DISLOCATION TO THE PATIENT THRASHING AND MOVING AROUND IN THE MIDDLE OF THE NIGHT. THEREFORE, THERE WAS NO ALLEGED PRODUCT DEFECT ASSOCIATED WITH THE DISLOCATION AND THE RECORD WILL BE UPDATED TO NOT A COMPLAINT.
Patient problems: Joint Dislocation
MAUDE report 11393487 ↗
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, ClassifiedRingLoc 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 · TerminatedRINGLOC 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-1860-2017 · Feb 17, 2017 · Terminatedvarious 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, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
- Compress® Device 178552Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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