R3 71338691Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556113141), received between Nov 21, 2019 and Nov 21, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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.

• InjuryNov 21, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR THE THIRD TIME. ASEPTIC LOOSENING. HIP PREPPED AND DRAPED, JOINTLY OPENED, SPECIMENS TAKEN. JOINT LAVAGED AND DEBRIDED INTENSELY. THE FEMORAL HEAD REMOVED, POLY LINER AND CUP AND SCREWS REMOVED. EXISTING SOCKET REAMED TO A BLEEDING BONE BED. IMPLANT TRIALED, JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE. DEFINITIVE ACETABULAR IMPLANT INSERTED WITH BONE CEMENT. TRIPOLAR LINER/HEAD TRIALED VIA REDUCTION, HIP STABLE, DEFINITIVE TRIPOLAR IMPLANTS INSERTED AND HIP REDUCED, HIP CLOSED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9360115 ↗
• InjuryNov 21, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR THE THIRD TIME. ASEPTIC LOOSENING. HIP PREPPED AND DRAPED, JOINTLY OPENED, SPECIMENS TAKEN. JOINT LAVAGED AND DEBRIDED INTENSELY. THE FEMORAL HEAD REMOVED, POLY LINER AND CUP AND SCREWS REMOVED. EXISTING SOCKET REAMED TO A BLEEDING BONE BED. IMPLANT TRIALED, JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE. DEFINITIVE ACETABULAR IMPLANT INSERTED WITH BONE CEMENT. TRIPOLAR LINER/HEAD TRIALED VIA REDUCTION, HIP STABLE, DEFINITIVE TRIPOLAR IMPLANTS INSERTED AND HIP REDUCED, HIP CLOSED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9353583 ↗

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.