R3 71336952Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010622556), received between Feb 20, 2018 and Dec 4, 2019 — classified as 3 injuries, 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K113848, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MRI DEMONSTRATED MILD DIFFUSE FATTY INFILTRATION. RIGHT HIP ASPIRATION WAS PERFORMED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 9409352 ↗
• InjurySep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011 A MEDICAL INTERVENTION WAS PERFORMED DUE TO PAIN. A STEROID INJECTION WAS PERFORMED TO TREAT SEVERE PAIN THE PATIENT WAS PRESENTING.

  Patient problems: Injury

  MAUDE report 7879308 ↗
• MalfunctionSep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED ON (B)(6) 2010 DUE TO SWELLING. RIGHT HIP BURSA WAS INJECTED.

  Patient problems: Injury

  MAUDE report 7879022 ↗
• InjuryFeb 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO A MECHANICAL LOOSENING OF LEFT INTERNAL HIP PROSTHESIS.

  Patient problems: Injury

  MAUDE report 7284265 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113848, 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.
• Z-1929-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
• Z-1928-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.