NA 71302604Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010194084), received between Mar 27, 2017 and Jan 4, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A BIPOLAR HIP ARTHROPLASTY SURGERY THAT WAS PERFORMED ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 BECAUSE THE COCR 12/14 FEM HEAD 26 + 4 WAS DISASSOCIATED FROM THE TNDM BP SHL/XLPE LNR 42OD 26ID EVEN THOUGH THE POLY RING WAS LOCKED IN THE TANDEM BIPOLAR. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16098160 ↗
• InjuryNov 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A HIP HEMIARTHROPLASTY WITH A TANDEM BIPOLAR CONSTRUCT, WHEN THE SURGEON CHECKED HIP REDUCTION DURING PROCEDURE, THE COCR 12/14 FEM HEAD 26 + 4 BECAME DISASSOCIATED FROM TNDM BP SHL/XLPE LNR 42OD 26ID EVEN THOUGH THE POLY RING HAD NOT COME OFF. TANDEM BIPOLAR, INNER HEAD AND STEM WERE EXCHANGED TO ANOTHER SIZE PRODUCTS, WHICH CAUSED A LESS THAN 30 MIN DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839353 ↗
• InjuryJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A HIP REPLACEMENT SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT DISLOCATED THE AFFECTED HIP DUE TO A FALL. ON (B)(6) 2022 A REVISION SURGERY WAS PERFORMED AND IT WAS NOTICED THAT THE COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4 DISASSOCIATED FROM THE TANDEM BIPOLAR SHELL/XLPE LINER 45MM OUTER DIAMETER 26MM INNER DIAMETE, EVEN THOUGH THE POLY RING DID NOT DISASSEMBLE FROM THE OUTER HEAD. CURRENT HEALTH STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Dislocation

  MAUDE report 13282531 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2021, IT WAS REPORTED THAT A PATIENT EXPERIMENTED A DISLOCATION OF THE IMPLANT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 TO EVALUATE THE BEST WAY TO FIX THE PROBLEM AND THE ACETABULAR CUP AND LINER WERE REPLACED WITH ANOTHER COMPANY'S IMPLANTS. NEW SMITH AND NEPHEW FEMORAL HEAD IMPLANTED. IT IS UNKNOWN HOW FEMORAL HEAD WAS ABLE TO DISLOCATE OUT OF CONSTRAINED LINER. PATIENT CONDITION IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12285365 ↗
• InjuryJun 1, 2021Adverse 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 ON (B)(6) 2021, THE PATIENT SUFFERED FROM A DISLOCATION WITHOUT FALLING. A CLOSED REDUCTION AND REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11914310 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION, FEVER AND PAIN. HOWEVER, THE DEVICES WERE NOT DEFECTIVE. THIS WAS FOUND AFTER PROCEDURE.

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 11094985 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE FEMORAL HEAD WAS REPLACED WITH A COMPETITOR DEVICE DUE TO PAIN. IT IS UNKNOWN IF A DELAY HAPPENED DURING SURGERY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 10987198 ↗
• InjurySep 24, 2019Unstable; Unstable

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION THAT CAUSED BY PATIENT FALLING DOWN. THE LINER AND INNER HEAD WERE EXCHANGED.

  Patient problems: Joint Dislocation

  MAUDE report 9109316 ↗
• InjuryAug 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. HEAD AND LINER EXCHANGED.

  Patient problems: Injury

  MAUDE report 8942216 ↗
• InjuryJun 16, 2019Fracture; Fracture

  IT WAS PERFORMED THAT REVISION SURGERY WAS PERFORMED TO FIX FEMORAL FRACTURE CAUSED BY FALLING DOWN. THE SURGEON DOES NOT BLAME THE PRODUCT BECAUSE THE PATIENT HAS DEMENTIA.

  Patient problems: Injury

  MAUDE report 8702580 ↗
• InjuryJun 16, 2019Fracture; Fracture

  IT WAS PERFORMED THAT REVISION SURGERY WAS PERFORMED TO FIX FEMORAL FRACTURE CAUSED BY FALLING DOWN. THE SURGEON DOES NOT BLAME THE PRODUCT BECAUSE THE PATIENT HAS DEMENTIA.

  Patient problems: Injury

  MAUDE report 8702575 ↗
• InjurySep 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. BIPOLAR HEAD AND INNER HEAD WERE REMOVED AND ANTIBIOTIC-LOADED CEMENT WAS PLACED. STEM WAS REMAINED.

  Patient problems: Unspecified Infection

  MAUDE report 7908669 ↗
• InjuryAug 9, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7767887 ↗
• InjuryMar 27, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF THA. FOLLOWING PATIENT HIP DISLOCATION THE SURGEON TRED TO REDUCE THE HIP BY HAND AND AFTER BEING UNSUCCESSFUL PERFORMED A REVISION SURGERY. DURING A REVISION SURGERY SURGEON FOUND FEMORAL HEAD TO BE DISLOCATED.

  Patient problems: Failure of Implant; Joint Dislocation; No Code Available

  MAUDE report 6435030 ↗

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.