RINGLOC HIP SYSTEM 14-103650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304229860), received between Apr 15, 2022 and Apr 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K030055, K921301); 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.

• MalfunctionApr 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN INITIAL HIP REPLACEMENT SURGERY, THE INTERNAL RING OF THE CUP CAME OUT AND LOOPED ON THE CUP IMPLANTATION ROD. DURING THE REMOVAL OF THE CUP, IT RUBBED AGAINST THE SOFT TISSUE, CAUSING DEFORMATION OF THE RING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117391 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030055, K921301. One submission often covers many models, so check the product and lot details in each record.

• Z-0523-2020 · Aug 21, 2019 · Terminated
  Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-1
• Z-1754-2015 · Apr 16, 2015 · Terminated
  Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral
• Z-1122-2015 · Jan 9, 2015 · Terminated
  Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)