NA 71302200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010194039), received between Jul 6, 2017 and Feb 11, 2021 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT HAD A REVISION SURGERY FOR A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2020. PATIENT DEVELOPED A POST-OPERATIVE WOUND INFECTION WITH COLLECTION AT DISTAL END OF INCISION SITE. SURGEON REVISED FEMORAL HEAD AND DUAL MOBILITY HEAD OF CONSTRUCT WHILST PERFORMING DEBRIDEMENT AND WASHOUT OF WOUND. NO PROSTHESIS RETRIEVED AS SURGEON SENT THEM FOR PATHOLOGY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11314299 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT SOME POINT IN THE LAST 3 MONTHS, THIS PATIENT HAD A FALL ONTO THEIR THR, WHICH RESULTED IN THE CONSTRAINED R3 LINER LOCKING RING BREAKING, THEREFORE LEADING TO INSTABILITY AND DAMAGE TO THE LINER. THE REVISION SURGERY WAS PERFORMED AND THE LINER AND HEAD WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 10444580 ↗
• MalfunctionApr 11, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SURGERY, A 22MM AND ZERO HEAD WAS ABOUT TO BE IMPLANTED BUT SURGEON NOTED THAT THE HEAD LOOKED VERY BIG FOR A 22MM. WHEN THE STAFF CHECKED THE INSIDE OF THE IMPLANT, NOTED THAT IT WAS A 28MM MINUS 3 AND NOT THE SIZE AS PER PACKAGING. THE NURSE CONFIRMED THAT THE BOX WAS SEALED. THERE WAS A DELAY OF LESS THAN THIRTY MINUTES AND PROCEDURE WAS CONCLUDED WITH A BACKUP DEVICE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9951232 ↗
• MalfunctionMar 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PRIMARY PROCEDURE 12 YEARS AGO, THE INCORRECT SIZE OF THE FEMORAL HEAD WAS IMPLANTED. DR. REALIZED ABOUT THIS WHEN HE WAS TRYING TO PERFORM REVISION SURGERY. THE IMPLANT COULD NO BE EXPLANTED BECAUSE THE SIZE AVAILABLE AT THAT MOMENT WAS NOT THE CORRECT ONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831399 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RE-OPERATION WAS PERFORMED DUE TO DISLOCATION. COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0 WAS NOT EXPLANTED BUT REPOSITIONED. DURING THIS PROCEDURE, THE SURGEON REALIZED THAT THERE WAS A MISMATCH BECAUSE THE SIZE OF THIS SPECIFIC DEVICE DID NOT MATCH WITH THE PRIMARY PROCEDURE OPERATIVE NOTES (PERFORMED ON (B)(6) 2007) PROVIDED BY THE HOSPITAL. THEREFORE, DR. WAS NOT ABLE TO EXCHANGE THE IMPLANT (NEW DEVICE WAS A DIFFERENT SIZE). THE DOCTOR STATED THAT THIS DISLOCATION WAS NOT CAUSED BY THE DEVICES BUT THE PATIENT'S DISEASE.

  Patient problems: Joint Dislocation

  MAUDE report 9824103 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO A TUMOR INGRESS.

  Patient problems: Injury

  MAUDE report 8929135 ↗
• InjuryDec 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATIENT (B)(6) SUFFERED A DISLOCATION SEVEN WEEKS AFTER HER HIP REPLACEMENT.

  Patient problems: Joint Dislocation

  MAUDE report 8124323 ↗
• InjuryJul 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6690228 ↗

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.