NA 71303203Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010194183), received between Sep 17, 2018 and Dec 6, 2024 — classified as 5 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED A CHRONIC DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A COCR 12/14 FEM HEAD 32 - 3 AND A R3 20 DEG XLPE ACET LNR 32MM X 48MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20873204 ↗
• MalfunctionAug 24, 2022Positioning Failure; Scratched Material; Positioning Failure; Scratched Material

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3 DID NOT FIT PROPERLY WITH THE STEM. AN UNSPECIFIED ABNORMALITY IN SHAPE/SIZE/DIMENSIONS/OTHER CHARACTERISTIC WAS VISUALLY CONFIRMED ON THE REPORTED FEMORAL TAPER. SURGERY WAS RESUMED, WITHOUT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287972 ↗
• InjuryApr 22, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT LEFT THA WAS PERFORMED ON (B)(6) 2016. AFTER THAT, THE PATIENT DEVELOPED PAIN AND SEVERE LIMP. LEFT REVISION SURGERY WAS PERFORMED IN (B)(6) 2017 AND TAPER FEMORAL HEAD.

  Patient problems: Injury; Pain

  MAUDE report 9989018 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SWELLING AND PAIN. LINER, HEAD AND STEM WERE REMOVED.

  Patient problems: Swelling

  MAUDE report 9281471 ↗
• MalfunctionApr 29, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING SURGERY WHEN THE INSERT IMPLANT WAS OPENED IN OR THE PLASTIC MATERIAL FROM THE WRAPPING WAS STUCK ON THE COCR HEAD. THERE WAS NO NEW HEAD OF THE SAME SIZE AVAILABLE, THE SURGEON WAS FORCED TO TAKE A LARGER SIZE. MORE THAN 30 MINUTES DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561059 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO ON GOING PAIN. HEAD, CUP AND LINER WERE REMOVED, NEW DEVICES WERE INSERTED.

  Patient problems: Pain

  MAUDE report 8491842 ↗
• InjurySep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE IMPLANTS STRYKER ALL POLY CUP, CPCS STEM AND HEAD DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7880928 ↗

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.