NA 71302803Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010194121), received between Feb 11, 2018 and Apr 12, 2021 — classified as 10 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 (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT TO PRIMARY TOTAL HIP REPLACEMENT ON (B)(6) 1998. RECENTLY, THE PATIENT COMPLAINED OF PAIN, AND A REVISION SURGERY WAS PERFORMED. THE REFLECTION LINER 28 MM ((B)(4)) AND THE COCR FEMORAL HEAD ((B)(4)) WERE REVISED. THE EXPLANTED IMPLANTS WERE REPLACED USING A REFLECTION LINER 32 MM AND AN OXINIUM FEMORAL HEAD. DURING REVISION WAS FOUND THAT THE ORIGINAL LINER HAD WORN AND WAS CAUSING INSTABILITY. THE OUTCOME OF THE PATIENT IS UNKNOWN

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 11648408 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PERFORMED ON JULY 2 DUE TO DISLOCATED ACETABULAR COMPONENT. COCR HEAD REMOVED AS PART OF THAT EXTRACTION OF DISLOCATED DEVICES. IT WAS IMPLANTED REDAPT MODULAR SHELL WITH LOCKING SCREWS AND CONSTRAINED LINER AND OX 22 +0 HEAD. PATIENT STILL IN HOSPITAL. SEEMED QUITE UNWELL, WITH BLOOD TRANSFUSION RUNNING PRIOR TO CASE START. THE ADVERSE EVENT HAPPENED NOT DUE TO FAULTY S+N PRODUCT.

  Patient problems: Injury

  MAUDE report 10324898 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOW HAEMOGLOBIN AND LOW BLOOD PRESSURE. PATIENT RECEIVED 2 UNITS OF BLOOD TRANSFUSION.

  Patient problems: Injury

  MAUDE report 9670982 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN IN THIGH EXTERNAL AND INTERNAL ROTATION

  Patient problems: Pain

  MAUDE report 8628221 ↗
• InjuryApr 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A LEFT SIDE THA AT (B)(6) PUBLIC (B)(6) 2019 WITH A SPECTRON/POLARCUP CONSTRUCT VIA A POSTERIOR APPROACH. PATIENT HAS MEDICAL HISTORY OF KIDNEY TRANSPLANT. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT (DONE BY ANOTHER SURGEON) AS WELL AS VAC DRESSINGS, PRIOR TO FIRST STAGE REVISION ON (B)(6) 2019. DR. PERFORMED FIRST STAGE REVISION HIP SURGERY ON (B)(6) 2019 REMOVING ACETABULAR IMPLANTS WITH ZIMMER EXPLANT AND USING RENOVATION HIP TO REMOVE FEMORAL COMPONENT. SURGEON PERFORMED AN ETO AND REMOVED CEMENT FROM FEMUR WITH RENOVATION INSTRUMENTS. ACETABULUM REAMED AND FEMUR REAMED. WOUND DEBRIDED AND IRRIGATED WITH SALINE AND BETADINE AND FEMUR CABLED WITH CIRCLAGE WIRE TEMPORARILY. WOUND CLOSED, AND THEN PT RE-PREPPED AND DRAPED WITH WHOLE NEW SETUP. PT THEN REOPENED AND THEN DALLMILES CABLES APPLIED TO FEMUR AND ZB HIP CEMENT SPACER INSERTED WITH PALACOS COPAL CEMENT LOADED WITH ANTIBIOTIC USED TO FIX HIP CEMENT SPACER. WOUND IRRIGATED AND CLOSED IN LAYERS.

  Patient problems: Unspecified Infection

  MAUDE report 8489146 ↗
• InjuryMar 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT PRIOR TO FIRST STAGE REVISION ON (B)(6) 2019, ACETABULAR IMPLANTS AND FEMORAL COMPONENT WERE REMOVED. ANTIBIOTIC CEMENT SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8468047 ↗
• InjuryJun 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP DISLOCATING.

  Patient problems: Joint Dislocation

  MAUDE report 7611583 ↗
• InjuryMay 22, 2018Corroded; Corroded

  IT WAS REPORTED THAT THE SURGEON HAS REMOVED THE 28MM COBALT CHROME HEAD -3 AND HAS NOTICED THE ITEM HAS EXCESSIVE WEAR AND IS HEAVILY OXIDISED.

  Patient problems: Injury

  MAUDE report 7533323 ↗
• InjuryMay 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FALL.

  Patient problems: Injury

  MAUDE report 7509200 ↗
• InjuryFeb 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY PERFORMED.

  Patient problems: No Information

  MAUDE report 7262563 ↗

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.