NA 71303208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010194206), received between Dec 11, 2017 and Jul 4, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14911760 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. NO OTHER COMPLICATIONS WERE REPORTED. DETAILS ABOUT THE SURGERY, AND IF THE PATIENT RECEIVED ANY MEDICATION TO TREAT THE INFECTION ARE UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11922528 ↗
• MalfunctionDec 15, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING SURGERY, WHILE OPENING THE PACKAGING OF THE FEMORAL HEAD, IT GOT STUCK TO THE PIECE ITSELF. IT WAS NOT POSSIBLE TO ELIMINATE THE ENTIRE PLASTIC PACKAGE ATTACHED TO THE PRODUCT AND PROCEDURE WAS CONCLUDED WITH A BACK-UP DEVICE FROM SMITH AND NEPHEW AND WITH A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11010836 ↗
• InjuryJan 5, 2019Corroded; Corroded

  IT WAS REPORTED THAT A REVISION SURGERY OF A TOTAL HIP ARTHROPLASTY WAS PERFORMED DUE TO METAL ON METAL DUAL TAPER CORROSION WITH ADVERSE TISSUE REACTIONS WITH EXTENSIVE ABDUCTOR NECROSIS AND PROXIMAL FEMORAL OSTEOLYSIS. DURING SURGERY THE SURGEON FOUND ROUGHLY 200CC OF METALLIC STAINED FLUID UNDER TENSION, THERE WAS SIGNIFICANT NECROSIS WITHIN THE JOINT AND MORE THAN 50% OF THE ABDUCTORS WERE NECROTIC, A SIGNIFICANT AMOUNT OF NECROTIC SOFT TISSUE WAS REMOVED. THE IMPLANTS REMOVED WERE THE STEM, FEMORAL HEAD AND MODULAR NECK, WHICH HAD SIGNIFICANT CORROSION IN IT. THE MONTHS PRIOR TO THE REVISION SURGERY, THE PATIENT WAS COMPLAINED OF PAIN AND WHEN TO THE HOSPITAL ON (B)(6) FOR AN ORTHOPEDIC EVALUATION, DIAGNOSED X-RAYS WERE OBTAINED AS WELL AS A CT SCAN OF THE PELVIS AND THE HIP, AFTER EVALUATION THE PATIENT WAS REFERRED TO SSH FOR A FLUOROSCOPIC GUIDED ARTHROCENTESIS OF THE RIGHT HIP. ALSO, LABS ANALYSIS WERE TAKEN AND THE PATIENT WAS FOUND TO HAVE A COBALT METAL ION LEVEL OF 9.5, CHROMIUM LEVEL OF 1.4, C-REACTIVE PROTEIN LEVEL OF 13.6, AND SEDIMENTATION RATE OF 57. ON (B)(6) AN MRI REVEALED A 6X2X3.3CM FLUID COLLECTION ABOUT THE GREATER TROCHANTER AND ATROPHY OF GLUTEUS. ON (B)(

  Patient problems: Injury; Tissue Damage

  MAUDE report 8220595 ↗
• InjuryFeb 6, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH SEVERAL EPISODES OF SUBLUXATION OF HER RIGHT HIP, NOT TRUE DISLOCATION. THE SURGEON BELIEVED THE SKIRT ON THE METAL HEAD WAS IMPINGING AND CAUSING THE SUBLUXATION. THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT REVISION SURGERY. THE HEAD AND LINER WERE REPLACED AND SOFT TISSUE ANTERIORLY WAS ALSO DEBRIDED.

  Patient problems: Joint Disorder

  MAUDE report 7245671 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO DISLOCATION, ALL PARTS WERE REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 7140017 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE PARTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7104636 ↗

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.