MATRIX MH0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010007384), received between Apr 4, 2021 and Apr 4, 2021 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K211176, K921400); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A HIP REPLACEMENT REVISION SURGERY WAS PERFORMED DUE TO EXCESSIVE WEAR AND REOCCURRING DISLOCATION. THE ZIRC 14/6 FEM HD 28 +4 AND THE MTX TPR SLEEVE +0 WERE EXCHANGE. THE JOINT WAS VERY STABLE. THE REFLECTION CUP AND THE RMHS STEM SEEMED TO BE STABLE AND NO FURTHER ACTION WAS TAKEN. NO OTHER COMPLICATIONS WERE REPORTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN THE PATIENTS CURRENT HEALTH STATUS.

  Patient problems: Joint Dislocation

  MAUDE report 11612119 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K921400. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.