NA 71344247Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556022757), received between Nov 5, 2018 and Dec 2, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K093363, 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.

• InjuryDec 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD INCREASED NICKEL, TITANIUM AND VANADIUM LEVELS. NO TREATMENT HAS BEEN GIVEN TO PATIENT.

  Patient problems: Injury

  MAUDE report 8123226 ↗
• InjuryDec 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD INCREASED NICKEL, TITANIUM AND VANADIUM LEVELS. NO TREATMENT HAS BEEN GIVEN TO PATIENT.

  Patient problems: Injury

  MAUDE report 8123223 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED INCREASED NICKEL LEVELS IN 2014 AS 2.39. IN (B)(6) 2018, IT WAS REPORTED A DECREASED NICKEL LEVEL BUT WERE STILL ABOVE UPPER LIMIT WITH VALUE OF 1.2.

  Patient problems: Injury

  MAUDE report 8105841 ↗
• InjuryNov 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED INCREASED NICKEL LEVELS IN 2014 AS 2.39. IN (B)(6) 2018, IT WAS REPORTED A DECREASED NICKEL LEVEL BUT WERE STILL ABOVE UPPER LIMIT WITH VALUE OF 1.2.

  Patient problems: Injury

  MAUDE report 8100392 ↗
• InjuryNov 5, 2018High Test Results; High Test Results

  IT WAS REPORTED THAT PATIENT PRESENTS INCREASED TITANIUM LEVEL DUE TO TITANIUM IS PRESENT IN IMPLANTED COMPONENTS . TITANIUM LEVEL 3.64 (UPPER REFERENCE RANGE PER ALS (B)(6) AB IS 2.96).

  Patient problems: Patch Test, Abnormal Results Of; Test Result

  MAUDE report 8039640 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093363, 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.