RingLoc® Hip System 103536Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304185708), received between Jan 9, 2026 and Jan 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K082446, K912245, K971890, K990032, K991807); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE LOSS WITH IMPLANT MIGRATION AND LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE IS PENDING. IT WAS NOTED THAT THE PATIENT HAS A HIGHER BODY WEIGHT (REPORTED TO BE 300+). A NEW TRIFLANGE IMPLANT IS CURRENTLY IN PROCESS WITH THE MANUFACTURER, AND A REVISION DATE HAS NOT YET BEEN SCHEDULED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis

  MAUDE report 24020642 ↗
• InjuryJan 9, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE LOSS WITH IMPLANT MIGRATION AND LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE IS PENDING. IT WAS NOTED THAT THE PATIENT HAS A HIGHER BODY WEIGHT (REPORTED TO BE 300+). A NEW TRIFLANGE IMPLANT IS CURRENTLY IN PROCESS WITH THE MANUFACTURER, AND A REVISION DATE HAS NOT YET BEEN SCHEDULED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis

  MAUDE report 24020607 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082446, K912245, K971890, K990032, K991807. One submission often covers many models, so check the product and lot details in each record.

• Z-0627-2021 · Nov 25, 2020 · Terminated
  RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthe
• Z-0621-2021 · Nov 25, 2020 · Terminated
  Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheu
• Z-1087-2019 · Mar 1, 2019 · Terminated
  Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant
• Z-1086-2019 · Mar 1, 2019 · Terminated
  Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
• Z-2135-2011 · Mar 10, 2011 · Terminated
  Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetab