Tandem 71326600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010196545), received between Sep 10, 2019 and Dec 15, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, DUE TO INFECTION A TWO STAGES REVISION SURGERY WAS PERFORMED. ON THE FIRST STAGE THE TANDEM UNIPOLAR HEAD 54MM ((B)(4)), THE TANDEM UNIPOLAR 12/14 TAPER SLEEVE + 0 ((B)(4)) AND THE SPECTRON EF 12/14 TAPER LONG STRAIGHT 225MM SMALL ((B)(4)) WERE EXPLANTED AND A REVISION LONG STEM SPECTRON WITH A TANDEM UNIPOLAR HEAD, COATED IN ANTIBIOTIC CEMENT WERE PLACED INTO THE PATIENT. THE SECOND STAGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXTRACT THE DEVICES THAT WERE PUT IN ON THE FIRST STAGE SURGERY AND TO EXCHANGE THEM WITH THE IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13012912 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A HEMI ARTHROPLASTY, AND DISLOCATED APPROX 9 DAYS AFTER SURGERY. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE TANDEM UNI 12/14 TPR SLV + 0 ((B)(4)) AND TANDEM UNIPOLAR 48MM ((B)(4)) FOR A BIPOLAR HEAD SIZE 47. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12053654 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT HIP HEMIARTHROPLASTY PERFORMED ON (B)(6) 2020, PATIENT'S PRIMARY WOUND FAILED TO HEAL, WITH ONGOING DISCHARGE FROM WOUND. PATIENT HAD REVISION WASHOUT AND HEAD EXCHANGE FOR INFECTION ON (B)(6) 2020. IMPLANTS ARE NOT AVAILABLE SINCE THEY WERE SENT FOR PATHOLOGY TESTING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 11010876 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY, THE PATIENT SUFFERED A DISLOCATION. A REVISION SURGERY WAS PERFORMED TO TREAT THE EVENT: THE TANDEM UNIPOLAR TAPER SLEEVE WAS EXPLANTED AND REPLACED WITH A OR3O IMPLANT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10026284 ↗
• InjurySep 10, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION. THE ACETABULUM HAD A SIGNIFICANT DEFORMITY IN THE ANTERIOR PART AND IT WAS CHANGED TO GAIN STABILITY OF THE JOINT.

  Patient problems: Injury

  MAUDE report 8981054 ↗