REGENEREX RINGLOC + HIP SYSTEM PT-116054Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304451452), received between Apr 13, 2020 and Apr 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

19 other recalls cover devices cleared under the same FDA submission (K070369); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2020Fracture; Fracture

  IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO PAIN AND POLYETHYLENE WEAR. DURING THE REVISION, IT WAS NOTED THAT THE LOCKING RING WAS FRACTURED. THE LINER AND LOCKING RING WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 9954175 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070369. One submission often covers many models, so check the product and lot details in each record.

• Z-2454-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 56 mm Size 24, with Lock Ring, sterile, REF PT-106056, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2461-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, sterile, REF PT-116048, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ring
• Z-2453-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 54 mm Size 23, with Lock Ring, sterile, REF PT-106054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2462-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, sterile, REF PT-116050, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringl
• Z-2457-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, sterile, REF PT-106064, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2459-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, sterile, REF PT-106070, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2451-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring w/Plug, sterile, REF PT-104062, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenere
• Z-2466-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, sterile, REF PT-116060, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ring
• Z-2455-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, sterile, REF PT-106060, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2464-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, sterile, REF PT-116054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ring
• Z-2448-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring w/Plug, sterile, REF PT-104050, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous
• Z-2458-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, sterile, REF PT-106066, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is
• Z-2465-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking Ring, sterile, REF PT-116056, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ring
• Z-2463-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking Ring, sterile, REF PT-116052, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringl
• Z-2460-2011 · Apr 14, 2011 · Terminated
  Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, sterile, REF PT-106074, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is

…and 4 more.