NA 71336525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010197665), received between Nov 12, 2018 and May 14, 2023 — classified as 1 injury, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K211176, K920430); 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.

• MalfunctionMay 14, 2023Fracture; Fracture

  IT WAS REPORTED, THAT, DURING A THR. WHILE A UNIV CAN ACET SCREW 25MM, WAS BEING INSERTED INTO THE CUP. A METAL SHAVING BROKE OFF THE SCREW. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928306 ↗
• InjuryNov 12, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AFTER THE R3 ACETABULAR CUP WAS IMPLANTED, IT WAS FIXED WITH A 25MM SCREW. POSTOPERATIVE X-RAY SHOWS THAT THE SCREW FELL OUT OF THE ACETABULAR CUP.

  Patient problems: No Code Available

  MAUDE report 8062773 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K920430. 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.