NA 11909Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556008720), received between Jun 12, 2020 and Jun 21, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072817, 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.

• InjuryJun 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2005, THE PATIENT EXPERIENCED DISCOMFORT AND DISLOCATION.THE SURGEON STATED THAT THIS EVENT WAS DUE TO THE WEAKENING OF THE PATIENT'S MUSCLES. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, IN WHICH ONE (1) UNIV COCR 10/12 TAPER FEM HD 26MM -5 WAS EXPLANTED AND EXCHANGED TO AN OX HEAD. THE ORIGINAL LINER, CUP AND STEM REMAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Joint Dislocation

  MAUDE report 22303906 ↗
• InjuryJun 12, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, AFTER A BHA SURGERY WITH ACCORD CABLE PERFORMED ON MAY 1ST, DURING REHABILITATION ON MAY 14TH, IT WAS NOTICED A SQUEAKING/NOISE COMING OUT FROM THE PATIENT'S HIP. AFTER A CHEST X-RAY EXAMINATION, IT WAS NOTICED THAT THE FEMORAL HEAD DISLOCATED FROM THE TANDEM COMPONENT. THE PATIENT HAD TO UNDERGO A REVISION SURGERY TO CORRECT THE ISSUE. THE PATIENT HAD THE FOLLOWING DEVICES IMPLANTED: TANDEM BIPOLAR SHELL/XLPE LINER 42MM OD 26MM ID, UNIVERSAL FEMORAL HEAD {} COCR 26MM -5EXT, SYN SEL II CEM SO 10/12 SZ11, INVIS DISTAL CENTRALIZER SIZE 8MM, AND BUCK FEMORAL CEMENT RESTRICTOR 18.5MM; HOWEVER, IT IS STILL UNKNOWN WHICH DEVICES WERE EXPLANTED. THE PATIENT OUTCOME IS ALSO UNKNOWN.

  Patient problems: Injury

  MAUDE report 10148621 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072817, 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.