SMF 71352701Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556159149), received between Sep 29, 2018 and Oct 1, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K123012, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING A FOLLOW-UP CALL, THAT PATIENT HAD A DRAINAGE ON (B)(6) 2016 DUE TO BURSITIS

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7924587 ↗
• InjurySep 29, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING A PHONE CALL FROM THE PATIENT STATING THE SMS STEM IMPLANTED IN (B)(6) 2015 IS CAUSING A PAIN AND THOUGHT TO BE LOOSE. THE PATIENT STATED THE STEM FEELS AS IF IT COULD DISLOCATE. HE WILL BE CHECKING WITH HIS PHYSICIAN SOON AND ASK FOR MEDICAL RECORDS. NO REVISION HAS BEEN PERFORMED TO DATE. PATIENT ALSO CALLED ON (B)(6) 2018 TO REPORT THAT HE HAD AN MRI DONE TO SEE WHAT THE ISSUE IS.

  Patient problems: Injury; Radiation Exposure, Unintended

  MAUDE report 7921211 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123012, 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.