R3 71338688Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556113172), received between May 26, 2019 and Jan 31, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093363, K211176); 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 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE HIP WAS DISLOCATED AND THE OXINIUM HEAD WAS REMOVED. THE ACETABULUM WAS EXPOSED AND THE LINER WAS REMOVED. FOLLOWING THIS, THE HIP WAS IRRIGATED WITH A ZIMMER ANTIBIOFILM SOLUTION FOR 1 LITER FOLLOWED BY 3 LITERS OF BACITRACIN IN SALINE. ALL DEVITALIZED TISSUE AND EXUDATE WERE ALL DEBRIDED. A NEW LINER WAS PLACED IN THE SAME POSITION AS THE PREVIOUS LINER WITH ANTERIOR HOOD AND SAME SIZE HEAD AND NECK, 40 MM WAS APPLIED. THE HIP WAS REDUCED AND STABLE WITH A FULL RANGE OF MOTION. ANTIBIOTIC DUSTING WITH VANCOMYCIN AND TOBRAMYCIN WAS CARRIED OUT AND THEN THE SURGICAL INTERVALS WERE REAPPROXIMATED WITH MONOFILAMENT SUTURE OVER 4 HEMOVAC DRAINS. AN INCISIONAL WOUND VAC WAS APPLIED. EIGHT DAYS AFTER THE REVISION SURGERY THE PATIENT DEVELOPED AN HEMATOMA AND IT WAS SURGICALLY EVACUATED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9652866 ↗
• InjuryMay 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LEFT HIP DISLOCATION HAS OCCURRED. PATIENT REQUIRED CLOSED REDUCTION TO AMEND.

  Patient problems: Injury

  MAUDE report 8643157 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093363, K211176. 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.