NA 71303612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010480019), received between May 10, 2019 and Nov 15, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW COMPONENT. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 15797679 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WENT TO THE DOCTOR DUE TO LEFT HIP PAIN, RATED AS 8 OUT OF 10 BOTH AT REST AND WHEN ACTIVE. AN MRI OF HIS LEFT HIP WAS PERFORMED ON (B)(6) 2017 AND REVEALED A LARGE COMPLEX SOFT TISSUE FLUID COLLECTION WITH SURROUNDING SOFT TISSUE AND MUSCLE EDEMA, REACTIVE MARROW SIGNAL CHANGES IN THE SUPERIOR AND ANTERIOR LEFT ACETABULUM AS WELL AS POSTERIOR PROXIMAL LEFT FEMUR AND ATROPHY OF THE GLUTEUS, MEDIUS AND MINIMUS MUSCLES ON THE LEFT. DUE TO THE LARGE FLUID COLLECTION THERE WAS LOSS OF A NORMAL ANATOMY WITH THE DISTAL LEFT GLUTEAL TENDON INSERTION SHOULD INSERT. DUE TO THE MRI FINDINGS, SURGEON FELT THAT PATIENT LIKELY HAD TAPER CORROSION. SURGEON DETERMINED THAT THE PATIENT WOULD NEED HEAD EXCHANGE. HIS COBALT AND CHROMIUM LEVELS WERE FOUND TO BE 4.6 AND 2.6 RESPECTIVELY. ON (B)(6) 2017 A LEFT HIP REVISION SURGERY WAS PERFORMED FOR TRUNNIONOSIS, METAL DEBRIS LEFT HIP, AND NECROSIS OF SOFT TISSUE, INCLUDING ABDUCTOR, TROCHANTER OF THE LEFT TOTAL HIP. INTRAOPERATIVELY, SURGEON IDENTIFIED THE VASTUS LATERALIS, HOWEVER, THERE WAS NO SIGNIFICANT POSTERIOR STRUCTURES. THE PATIENT HAD ABOUT 2CM THICK LAYER OF WHITE NECROTIC TISSUE TROCHANTERIC BONE THROUGHOUT AND

  Patient problems: Injury

  MAUDE report 8600774 ↗

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.