R3 71331094Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556113646), received between Nov 15, 2019 and Nov 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 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.

• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A REVISION HIP, REMOVING A BHR CUP AND EMPERION STEM WITH BHR MODULAR HEAD. HE REPLACED THIS WITH A 76 MM R3 MULTIHOLE SHELL, A 40 MM ZERO DEGREES LINER AND A 23 MM X 240 MM SLEEVELESS REDAPT STEM. DURING THE TRIALING STAGE, IT WAS FOUND THAT THE SHOULDER OF THE STEM IMPINGED ON THE RIM OF THE CUP AT AROUND THE 10 O'CLOCK POSITIONS DURING ABDUCTION AND EXTERNAL ROTATION OF THE LIMB. HE TRIED VARIOUS COMBINATIONS OF HEAD LENGTHS, OFFSET LINER, AND NECK OPTIONS. HE FEELS THE CUP VERSION IS NORMAL AND THE SHOULDER OF THE STEM SHOULD NOT IMPINGE AT THIS POINT. NO MORE INFORMATION WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9328354 ↗

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.