TANDEM 71324044Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010494351), received between Nov 26, 2018 and May 17, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K023743, K211176, K231448); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, ON (B)(6) 2023, A THR SURGERY WAS PERFORMED, WHERE A TANDEM INTL BIPOLAR 44OD 28ID AND AN OXINIUM FEM HD WERE IMPLANTED, DUE TO A FRACTURE; AND LATER ON (B)(6) 2023 THE IMPLANT DISLOCATED DUE TO A LOCKING FAILURE, SO A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023. PATIENT'S HEALTH STATUS WAS REPORTED TO BE GOOD.

  Patient problems: Joint Dislocation

  MAUDE report 16948044 ↗
• InjuryMay 4, 2022Loosening 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) 2022, THE TANDEM INTL BIPOLAR 44OD 28ID AND COCR 12/14 FEM HEAD 28 +0 WERE FOUND COMPLETELY LOOSE. THE IMPLANTS WERE CHANGED USING TNDM BP SHL/XLPE LNR 42OD 26ID AND COCR 12/14 FEM HEAD 22 +0. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283198 ↗
• InjuryDec 16, 2021Loosening 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) 2021, THE TANDEM INTL BIPOLAR 44OD 28ID WAS FOUND COMPLETELY LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A EXPLANATION ON (B)(6) 2021. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13023136 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A DISLOCATION. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ADVERSE EVENT. THE TANDEM INTL BIPOLAR 44OD 28ID WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 10909242 ↗
• InjuryOct 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DESPITE WHAT SEEMED TO BE A SATISFACTORY IMPLANTATION, A REVISION SURGERY HAD TO BE DONE DUE TO DISLOCATION. THE BIPOLAR CUP WAS DISLOCATED AND DID NOT HAVE THE HEAD INSIDE IT WHEN THE PARTS WHERE REMOVED, DESPITE HAVING THE INTEGRAL AND WELL PLACED SAFETY RING. NEW DEVICES OF THE SAME REFERENCE WERE PLACE AS REPLACEMENT. BACK-UP AVAILABLE, NO DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 9216074 ↗
• InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A HIP REVISION WAS PERFORMED ON A PATIENT AFTER PRIMARY SPECTRON/TANDEM HIP DONE, TWO WEEKS PRIOR. THE TANDEM AND COCR FEMORAL HEAD WAS EXTRACTED AND REPLACED BY A R3 THREE-HOLE CUP WITH CONSTRAINED LINER AND 22MM COCR FEMORAL HEAD. THE PATIENT DISLOCATED AFTER THE PRIMARY SURGERY DUE TO CONTRACTIONS ¿ SHE IS SPASTIC.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8102238 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023743, K211176, K231448. 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.
• Z-0351-2017 · Aug 29, 2016 · Terminated
  TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 7132
• Z-0350-2017 · Aug 29, 2016 · Terminated
  TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051,