NA 71303603Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010479976), received between May 22, 2019 and May 19, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

1 other recall cover devices cleared under the same FDA submission (K022902, K211176); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED IMPINGEMENT OF THE FEMUR, LEADING TO PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION THR SURGERY ON (B)(6) 2025, IN WHICH A TENDON WAS RELEASED, AND THE COCR 12/14 FEM HEAD 36MM -3 WAS EXPLANTED. PATIENT IS DOING WELL AFTER REVISION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 22045334 ↗
• InjuryJan 10, 2025Adverse 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) 2023, DUE TO DISLOCATION THE SURGEON DETERMINED A REVISION WAS NECESSARY TO CORRECT PATIENTS ISSUES. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY PERFORMED (B)(6) 2024, IN WHICH THE COCR 12/14 FEM HEAD 36MM -3, THE R3 20 DEG XLPE ACET LNR 36MM X 52MM AND THE R3 20 DEG XLPE ACET LNR 36MM X 52MM WERE REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21126714 ↗
• InjuryJun 10, 2022Adverse 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) 2020, ON (B)(6) 2022 PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION, WHERE THE COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3 WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14655188 ↗
• MalfunctionMay 31, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING SET UP FOR A THR, WHEN INNER PACKAGING OF A COBALT CHROME 12/14 FEM HEAD 36MM -3 WAS OPENED, A HAIR WAS INSIDE THE PACKAGING. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909316 ↗
• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT. FEMORAL HEAD AND POLYETHYLENE LINER REPLACED. THE ACETABULAR SCREW AND HOLE COVER WAS REMOVED. THE FEMORAL HEAD PRESENTED METALLOSIS. THERE WAS NO CLINICAL EVIDENCE OF DEEP INFECTION. THERE WAS NO OBVIOUS EVIDENCE OF METALLOSIS BEYOND THE FEMORAL HEAD TRUNNION CONNECTION. NO EVIDENCE OF LOOSENING OF THE STEM OR ACETABULAR COMPONENT.

  Patient problems: Injury

  MAUDE report 8633197 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022902, K211176. 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.