RingLoc® Hip System 103533Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304008700), received between Jun 21, 2023 and Jul 13, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

1 FDA recall record name this device's identifier.

4 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.

Recalls naming this device

1. Mar 1, 2019Terminated

   Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

   Z-1087-2019 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 6 YEARS LATER DUE TO PAIN AND SLIGHTLY ELEVATED CHROMIUM LEVELS. THE INITIAL STEM WAS LEFT INTACT WHILE ALL OTHER COMPONENTS WERE REPLACED WITHOUT COMPLICATIONS. AFTER THE REVISION, THE PATIENT REPORTED ONGOING PAIN IN BILATERAL HIPS. THE SURGEON STATED HE FELT THE PATIENT HAD BILATERAL HIP TROCHANTERIC BURSITIS AND DISCUSSED INJECTIONS WITH THE PATIENT; HOWEVER, THE PATIENT DECLINED TREATMENT AND INTERVENTIONS. THE PATIENT TAKES CHRONIC OPIOIDS AND IS FOLLOWED BY PAIN MANAGEMENT FOR POLYARTHRALGIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 25796234 ↗
• 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 24020670 ↗
• InjuryNov 12, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT HIP REVISION. THE PATIENT FELL AND DISASSOCIATED THE IMPLANT FROM THE PELVIS. THE TRIFLANGE SCREWS HAD STARTED TO RIP OUT FROM THE PELVIS FOLLOWING THE FALL. NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 23534304 ↗
• InjuryJun 21, 2023Material Erosion; Migration; Material Erosion; Migration

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY 4 YEARS LATER. DURING THE REVISION SOME METALLOSIS WAS NOTED WITHIN THE SOFT TISSUES, ACETABULAR LINER WAS FRAGMENTED, THE HEAD HAD SIGNIFICANT METAL LIKE WEAR, AND ONE SCREW WAS PROMINENT OF 0.5MM WITHIN THE ACETABULUM. THE HEAD, LINER, TAPER, AND RINGLOC WERE REPLACED AND THE PROMINENT SCREW WAS REMOVED. THE JOINT WAS IRRIGATED WITHOUT DEBRIDEMENT AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 17169591 ↗

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-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-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-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