NA 71352112Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010619549), received between Sep 21, 2017 and Dec 30, 2024 — 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 (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY TEN YEARS AFTER A PRIMARY THR, PATIENT GOT REVISED DUE TO AN INFECTION. ALL IMPLANTS INCLUDING HIGH OFFSET NEUTRAL MODULAR NECK WERE REPLACED FOR COMPETITOR PRODUCTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 21036190 ↗
• InjurySep 12, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2013, THE PATIENT EXPERIENCED PAIN, METALLOSIS AND ELEVATED COBALT LEVELS. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE FEMORAL HEAD, ACETABULAR LINER, MODULAR NECK, AND THE FEMORAL PROSTHESIS WERE REMOVED AND REPLACED WITH A COMPETITOR¿S SYSTEM. INTRAOPERATIVELY, A BLACKENED DISCOLORATION DEEP IN THE FEMORAL END OF THE TRUNNION TAPER JUNCTION WAS NOTICED WHEN THE FEMORAL NECK WAS REMOVED FROM THE STEM. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS NECESSARY TO REMOVE THE FEMORAL COMPONENT, DURING WHICH A GREATER TROCHANTER FRACTURE OCCURRED. THERE WAS A MODERATE BONE LOSS OF THE PROXIMAL METAPHYSIS OF THE FEMUR AS A RESULT OF STEM REMOVAL GIVEN ITS COMPLEXITY, AS THE IMPLANT WAS FOUND TO BE COMPLETELY INGROWN DISTALLY. THE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY BED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. PATIENT HAS BEEN RECOVERING WELL FROM THE PROCEDURE, HIS COBALT LEVELS HAVE DROPPED TO 1.1 AND IS ABLE TO AMBULATE WITHOUT A CANE OR WALKER.

  Patient problems: Bone Fracture(s); Hip Fracture; Metal Related Pathology

  MAUDE report 15407839 ↗
• InjuryDec 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD INFECTION OF PROSTHETIC HIP JOINT AND LINER, HEAD AND NECK WERE EXCHANGED. STEM WAS STILL IMPLANTED AND THERE WAS A DULL REVISION OF THE ACETABULUM.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9448483 ↗
• InjuryJan 5, 2019Corroded; Corroded

  IT WAS REPORTED THAT A REVISION SURGERY OF A TOTAL HIP ARTHROPLASTY WAS PERFORMED DUE TO METAL ON METAL DUAL TAPER CORROSION WITH ADVERSE TISSUE REACTIONS WITH EXTENSIVE ABDUCTOR NECROSIS AND PROXIMAL FEMORAL OSTEOLYSIS. DURING SURGERY THE SURGEON FOUND ROUGHLY 200CC OF METALLIC STAINED FLUID UNDER TENSION, THERE WAS SIGNIFICANT NECROSIS WITHIN THE JOINT AND MORE THAN 50% OF THE ABDUCTORS WERE NECROTIC, A SIGNIFICANT AMOUNT OF NECROTIC SOFT TISSUE WAS REMOVED. THE IMPLANTS REMOVED WERE THE STEM, FEMORAL HEAD AND MODULAR NECK, WHICH HAD SIGNIFICANT CORROSION IN IT. THE MONTHS PRIOR TO THE REVISION SURGERY, THE PATIENT WAS COMPLAINED OF PAIN AND WHEN TO THE HOSPITAL ON (B)(6), FOR AN ORTHOPEDIC EVALUATION, DIAGNOSED X-RAYS WERE OBTAINED AS WELL AS A CT SCAN OF THE PELVIS AND THE HIP, AFTER EVALUATION THE PATIENT WAS REFERRED TO SSH FOR A FLUOROSCOPIC GUIDED ARTHROCENTESIS OF THE RIGHT HIP. ALSO, LABS ANALYSIS WERE TAKEN AND THE PATIENT WAS FOUND TO HAVE A COBALT METAL ION LEVEL OF 9.5, CHROMIUM LEVEL OF 1.4, C-REACTIVE PROTEIN LEVEL OF 13.6, AND SEDIMENTATION RATE OF 57. ON (B)(6), AN MRI REVEALED A 6X2X3.3CM FLUID COLLECTION ABOUT THE GREATER TROCHANTER AND ATROPHY OF GLUTEUS. ON (B

  Patient problems: Injury; Tissue Damage

  MAUDE report 8220584 ↗
• InjuryDec 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS. THE STEM, THE MODULAR NECK AND THE FEMORAL HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 8207179 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ASPIRATION ON THE LEFT HIP DUE TO AN INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8139688 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY OF THE MDF MODULAR NECK WAS PERFORMED DUE TO ELEVATED METAL IONS AND MILD SOFT TISSUE REACTION.

  Patient problems: Unspecified Infection

  MAUDE report 7954195 ↗
• InjurySep 13, 2018Break; Break

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. MECHANICAL FALL SECONDARY TO ETOH (ALCOHOL), FELL ON RIGHT SIDE, CAUSING PERIPROSTHETIC FRACTURE. SUBJECT HAD FEMORAL STEM, FEMORAL HEAD AND FEMORAL NECK REVISED.

  Patient problems: No Code Available

  MAUDE report 7875135 ↗
• InjuryMay 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO INFECTION, 3 HIP DEVICES WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7490627 ↗
• InjurySep 21, 2017Corroded; Corroded

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CORROSION BETWEEN FEMORAL STEM AND MODULAR NECK.

  Patient problems: Injury; Pain

  MAUDE report 6883089 ↗

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