NA 71352111Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010619532), received between Aug 29, 2018 and Jan 23, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K072417); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2025Corroded; Biocompatibility; Corroded; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON 2014, THE PATIENT EXPERIENCED ELEVATED IONS IN BLOOD AND CULTURES CAME BACK NEGATIVE FOR INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE HIP COMPONENTS (STANDARD OFFSET NEUTRAL MODULAR NECK, MODULAR SLEEVE +4MM 12/14, AND SMF STEM WITH STIKTITE SZ 1) WERE REVISED. AND THE HEMI HEAD 48MM STAYED IN THE PATIENT. NECROTIC TISSUE WAS FOUND. THERE WAS ALSO VISIBLE CORROSION IN THE STANDARD OFFSET NEUTRAL MODULAR NECK. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: High metal ion levels; Metal Related Pathology; Necrosis

  MAUDE report 21217080 ↗
• InjuryDec 7, 2021Biocompatibility; Biocompatibility

  US LEGAL, IT WAS REPORTED THAT, AFTER A LEFT THR ON (B)(6) 2012 DUE TO OSTEOARTHRITIS, PLAINTIFF HAS EXPERIENCED AN IMPLANT MECHANICAL FAILURE, SIGNIFICANT ELEVATED COBALT CHROMIUM LEVELS AND AN MRI SHOWED AN ABDUCTOR MUSCLE TENDON TEAR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE IT WAS FOUND A PSEUDOTUMOR ENGULFING THE ABDUCTOR MUSCLE, AFTER A DEBRIDED THERE WAS A LARGE DISRUPTION OF THE ENTIRE MUSCLE AND IT WAS NOTICED THE FEMORAL COMPONENT DOWN TO THE ACETABULAR COMPONENT AND CORROSION AT THE MODULAR NECK TO STEM INTERFACE. THE R3 3 HOLE ACET SHELL 56MM REMAINED AND WAS NOT EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Laceration(s); Metal Related Pathology

  MAUDE report 12953064 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THE STANDARD OFFSET NEUTRAL MODULAR NECK WAS REVISED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 10982999 ↗
• MalfunctionDec 10, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A PROLONGED SURGERY OF A TOTAL KNEE ARTHROPLASTY PROCEDURE, GREATER THAN 30 MINUTES DUE TO UNIT ABILITY OF HIGH OFFSET OPTION. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10982906 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS LEFT HIP ON (B)(6) 2018 DUE TO PAINFUL LEFT HIP AND POOR FUNCTION; FAILED LEFT TOTAL HIP REPLACEMENT; ADVERSE LOCAL TISSUE REACTION AND SUBSEQUENT INFECTION. AMONG THE INTRA-OPERATIVE FINDINGS AND DIAGNOSES WERE ASEPTIC LOOSENING AT THE MODULAR JUNCTION, CORROSION OF THE MODULAR NECK AND METALLOSIS. THE S&N HEAD, SLEEVE AND STEM WERE REMOVED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology; Unspecified Infection

  MAUDE report 10943375 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEEP POST OPERATIVE INFECTION (ECOLI) AND A REVISION SURGERY WAS PERFORMED TO REMOVE ALL COMPONENTS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10160688 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TRUNNION CORROSION AND PAIN ON THE LEFT HIP ON (B)(6) 2017.

  Patient problems: Injury

  MAUDE report 10022382 ↗
• InjuryDec 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER PRIMARY HIP REPLACEMENT, PATIENT HAD INFECTION OF PROSTHETIC HIP JOINT AND SHELL, LINER, NECK AND FEMORAL HEAD WERE EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9448554 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE MODULAR REDAPT STEM DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8626422 ↗
• InjuryJan 2, 2019Pitted; Pitted

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE MODULAR NECK BECAUSE PATIENT WAS HAVING A REACTION TO CORROSION ON THIS IMPLANT.

  Patient problems: Injury

  MAUDE report 8210607 ↗
• InjuryAug 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CHRONIC INFECTION AND METALLOSIS.

  Patient problems: Unspecified Infection

  MAUDE report 7827547 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072417. One submission often covers many models, so check the product and lot details in each record.

• Z-0946-2017 · Nov 15, 2016 · Terminated
  Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have f