Tandem 126646Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010079756), received between Sep 19, 2024 and Sep 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K231448, K896580); 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. How this data works · Data updated Oct 13, 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.

• InjurySep 19, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING A THA REVISION PERFORMED DUE TO AN INFECTION, THE INITIAL PLAN WAS TO RETAIN THE EXISTING CUP AND STEM WHILE REPLACING THE FEMORAL HEAD WITH AN OR3O IMPLANT. THE EXISTING COMPONENTS INCLUDED A METAL R3 LINER, 58 MM SHELL AND A HEMI HEAD 46MM. ALTHOUGH THE FEMORAL HEAD WAS SUCCESSFULLY REMOVED, THE SLEEVE REMAINED LODGED ON THE NECK-TRUNNION. THE SURGEON REQUESTED A TANDEM UNIPOLAR 46MM FOR THE REPLACEMENT; HOWEVER, HE WAS ADVISED THAT USING A UNIPOLAR HEAD WITH THIS CONSTRUCT WAS OFF-LABEL. BASED ON THE SIZE OF THE SHELL (58 MM) AND THAT THE SLEEVE WAS STUCK, THE RECOMMENDATION WAS TO REMOVE THE METAL R3 LINER, REPLACING IT WITH A XLPE R3 LINER, AND USING A 40 MM OXINIUM HEAD, AS THE UNIPOLAR HEAD WAS NOT SUITABLE FOR THE R3 METAL-ON-METAL CONSTRUCT. DESPITE HAVING MULTIPLE OPTIONS AVAILABLE IN THE OR AND BEING AWARE THAT IT WAS AN OFF-LABEL USE, THE SURGEON DECIDED TO PROCEED WITH THE TANDEM UNIPOLAR 46MM. THE HEAD WAS IMPACTED AND THE HIP WAS REDUCED. THE SURGEON REVIEWED THE X-RAYS AND WAS SATISFIED WITH THE RESULT. IT WAS MENTIONED THAT THE PATIENT WAS IN BAD SHAPE AND WOULD LIKELY BE REVISED SOON. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260053 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K231448, K896580. 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.