TANDEM 71322046Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010492456), received between May 17, 2017 and Aug 12, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K023743); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER THE SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED DISLOCATION AFTER FALLING FROM BED AND A CLOSED REDUCTION WAS ATTEMPTED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE TANDEM BIPOLAR COCR 46OD 28ID WAS REMOVED AND IT WAS NOTICED THAT THE 28MM HEAD WAS STILL ATTACHED TO THE STEM AND THE TANDEM BIPOLAR LOCKING RING WAS INTACT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22784853 ↗
• InjurySep 25, 2023Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON 28-AUG-2023, THE PATIENT EXPERIENCED A DISLOCATION, AS THE ENTIRE CONSTRUCT DISLOCATED FROM THE ACETABULUM. WHEN THIS WAS BEING REDUCED IN THE ER, ON (B)(6) 2023, THE INNER FEMORAL HEAD POPPED OUT OF THE BIPOLAR COMPONENT. THE CONSTRUCT WAS REPLACED WITH A NEW 46 OD COMPONENT AND A 28 +8 FEMORAL HEAD. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17814028 ↗
• InjuryDec 26, 2022Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY, HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT SUSTAINED A FALL AND THE COCR 12/14 FEM HEAD 28 + 4 OF THE TANDEM BIPOLAR BECAME DISASSOCIATED. THE SHELL WITH THE LOCKING RING REMAINED INTACT. HOWEVER THERE WAS WEAR AROUND THE LOCKING RING OF THE TANDEM BIPOLAR COCR 46OD 28ID WHERE THE BALL CAME OUT. THE LOCKING RING WAS REMOVED AND THE INNER BALL REPLACED ON (B)(6) 2022. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Dislocation

  MAUDE report 16048280 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY, PATIENT DEVELOPED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE BIPOLAR LINER THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10968583 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO PAINFUL RIGHT HIP BIPOLAR ARTHROPLASTY WITH EROSIVE CHANGES OF THE ACETABULUM. TAPER FEMORAL HEAD, SHELL/ UHMWPE LINER AND FEMORAL COMPONENT WERE EXCHANGED AND PROCEDURE WAS CONVERTED TO A TOTAL HIP REPLACEMENT. STEM WAS RETAINED.

  Patient problems: Injury; Pain

  MAUDE report 10551840 ↗
• InjuryApr 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATED BIPOLAR HIP, ON (B)(6) 2019 SURGEON TRIED TO REDUCE THE HIP AND HEAD DISSOCIATED FROM THE TANDEM BIPOLAR SHELL. ON (B)(6) 2019 A REVISION SURGERY WAS PERFORMED, IMPLANTS WERE REMOVED AND REPLACED.

  Patient problems: Injury

  MAUDE report 8559682 ↗
• InjuryJun 26, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED A REVISION SURGERY WAS REQUIRED DUE TO HIP PAIN. IT WAS DISCOVERED THE POLY LINER AND FEMORAL HEAD HAD DISASSOCIATED.

  Patient problems: Pain

  MAUDE report 6668513 ↗
• InjuryMay 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT PRESENTED WITH A DISLOCATED BIPOLAR SHELL. THE SURGEON ATTEMPTED TO REDUCE AND THE SHELL DISLOCATED FROM THE 28MM HEAD. A REVISION SURGERY WAS PERFORMED TO REMOVE THE CONSTRUCT.

  Patient problems: Joint Dislocation

  MAUDE report 6571873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023743. 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,