NA 71302600Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010194077), received between Apr 20, 2017 and Jan 30, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K211176, K963509); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT FELL AND SUFFERED FROM DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH WHEN TRYING MANUAL REDUCTION, IT WAS FOUND THE COCR HEAD WAS DISASSOCIATED FROM TANDEM BIPOLAR. THEREFORE, THE COCR 12/14 FEM HEAD 26 + 0, TNDM BP SHL/XLPE LNR 40OD 26ID AND SL-PLUS INTEGR MIA STEM WITH TI/HA 2 WERE EXCHANGE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 18608931 ↗
• InjuryOct 8, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THE FIRST REVISION TKA SURGERY WAS ON (B)(6) 2018. PATIENT SUFFERED DISLOCATION OF FEMORAL HEAD AND RETAINER RING FROM ACETABULAR SHELL AND CONSTRAINED LINER CONSTRUCT. PRIMARY SURGERY DATE UNKNOWN. SECOND REVISION (B)(6) 2020. NO INJURY REPORTED EXCEPT NEED FOR REVISION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10653064 ↗
• InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LEFT HIP PAIN. X-RAYS SHOWED SIGNALS OF POLY WEAR. LINER AND HEAD WERE REMOVED AND REPLACED. HIP WAS REDUCED AND STABLE.

  Patient problems: Pain

  MAUDE report 9068752 ↗
• InjuryFeb 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATION.

  Patient problems: Injury

  MAUDE report 8305992 ↗
• InjuryFeb 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER THE PRIMARY SURGERY, POSTERIOR DISLOCATION HAD BEEN OCCURRED TWICE.

  Patient problems: Injury

  MAUDE report 8305991 ↗
• InjuryNov 15, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. TANDEM AND INNER HEAD WERE REPLACED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8075933 ↗
• InjuryNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SEPARATION OF SUTURE OCCURRED. TANDEN AND INNER HEAD REPLACED FOR POSSIBLE INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8075666 ↗
• InjuryApr 20, 2017Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION HIP SURGERY WAS PERFORMED DUE TO LUXATION.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 6507732 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K963509. 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.