NA 1365-53-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 404 adverse event reports that list this exact device (DI 10603295033950), received between Jan 11, 2013 and Mar 13, 2026 — classified as 395 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (108 reports).

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 25 most recent of 404 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT THA WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY, THE IMPLANTS WERE MOM AND ARMD WAS SUSPECTED. ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION SURGERY FOR IMPLANTS REPLACEMENT. UPON INCISION, MILKY WHITE SYNOVIAL FLUID WAS OBSERVED, ALONG WITH DARK DISCOLORED SYNOVIAL MEMBRANE. THE CUP WAS COMPLETELY DISLODGED AND COULD BE EASILY REMOVED. AFTER REPLACING THE CUP WITH A COMPETITOR¿S IMPLANT, DELTA TS WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON BELIEVES THAT ARMD DUE TO MOM CAUSED THE CUP TO LOOSEN, RESULTING IN THE CUP DISLODGING DURING ACTIVITY.

  Patient problems: Foreign Body Reaction; Synovitis

  MAUDE report 24589599 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT THE TIP BROKE WHEN MAKING A PILOT HOLE FOR THE RETAINER SCREW. THERE WAS NO PATIENT INJURY, AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036795 ↗
• InjuryJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FALL AND DISLOCATED. CHANGED TO A HIGH OFFSET STEM. NO HARM TO PATIENT. NO DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 24036419 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD LINER WASH OUT, DOI: UNKNOWN, DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23923982 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR THE HEAD AND LINER FOR POSSIBLE INFECTION AND ELEVATED MARKERS. AFFECTED SIDE-UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23632303 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A THA SURGERY ON HIP JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE HEAD AND THE LINER DUE TO LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 23559585 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SOME PAIN IN HIP. PATIENT HAD PRIOR TOTAL HIP REPLACEMENT SURGERY AND HAD A METAL LINER AND METAL HEAD CONSTRUCT. PATIENT SHOWED ELEVATED LEVELS OF METAL IONS AND METALOSIS. SURGEON REMOVED METAL LINER AND HEAD. REPLACED A NEW POLY LINER AND CERAMIC HEAD. PATIENT WAS STABLE. DOI: UNKNOWN, DOE: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 23351903 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF RIGHT HIP METAL LINER AND FEMORAL HEAD WHICH WERE REPLACED WITH POLY LINER AND TS CERAMIC HEAD DUE TO ELEVATED ION LEVELS AND OSTEOLYSIS OF THE RIGHT GREATER TROCHANTER. NO OTHER COMPONENTS WERE REPLACED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 22951290 ↗
• InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON WAS REVISED THE IMPLANTED PRODUCTS DUE TO PATIENTS RECURRING DISLOCATIONS. DOI: (B)(6) 1995, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22938827 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22860440 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXCHANGED POLY AND HEAD AFTER WASHING OUT THE JOINT FOR INFECTION. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22814792 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL HIP, 15 YEARS OUT FROM THE ORIGINAL SURGERY. LEFT TOTAL HIP. SURGEON ELECTED TO REMOVE THE ACETABULAR LINER AND FEMORAL HEAD AND REPLACE WITH NEW IMPLANTS. DOI: (B)(6) 2009. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22805014 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS BEING REVISED DUE TO PAIN. SURGEON REMOVED THE 54MM PINNACLE CUP, TWO 30MM PINNACLE SCREW, THE 54- 36MM +410 DEGREE LINER AND THE 36 +8.5 ARTICULEZE HEAD. THESE WERE REPLACED WITH AN EMPHASYS 58MM THREE HOLE CUP, THREE SCREWS, A DUAL MOBILITY LINER AND DUAL MOBILITY HEAD WERE USED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 22636855 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR A WOUND I&D FOR DRAINAGE. THE WOUND IS NOT CONSIDERED INFECTED BUT CULTURE ARE PENDING. THE HEAD AND LINER WERE REMOVED AND REPLACED. THE WERE NO DELAYS. AFFECTED SIDE : LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22470007 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED HIP. THE HEAD AND LINER WAS EXCHANGED. ALSO, THE SECOND HEAD AND LINER WAS EXCHANGED. THERE WAS NO FURTHER INFORMATION TO REPORT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22006469 ↗
• InjuryMay 7, 2025Degraded; Naturally Worn; Degraded; Naturally Worn

  "(B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO METAL WEAR, REACTION, AND TRUNNIONS. AT REMOVAL THE FEMORAL HEAD SHOWED CORROSION. AT REMOVAL THE LINER SHOWED MINOR YELLOWING.

  Patient problems: Foreign Body Reaction

  MAUDE report 21978664 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A DEPUY HIP IMPLANT THAT WAS DONE 2 YEARS AGO AND IT FAILED, HAD A REVISION TWO YEARS LATER. PATIENT WAS UNABLE TO PROVIDED FURTHER INFORMATION AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information

  MAUDE report 21919216 ↗
• InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED HIP NUMEROUS TIMES. THE HEAD AND LINER WERE REVISED TO A DUAL MOBILITY CONSTRUCT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 21873682 ↗
• InjuryApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY IMPLANT DISLOCATED AND SURGEON NEEDED TO ADD MORE CONSTRAINT. PATIENT WAS REVISED. THERE WAS NO DELAY IN SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 21873600 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS INCREASING PAIN AND HEAD & LINER EXCHANGE WAS PERFORMED. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2003; DOR: (B)(6), 2025; AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21739663 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER AND HEAD WERE REVISED FOR DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21700150 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND DID A HEAD AND LINER SWAP. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21307115 ↗
• InjuryJan 31, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS AN IMPLANT CHANGE OF A METAL ON METAL HIP.

  Patient problems: Insufficient Information

  MAUDE report 21281922 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIP WASHOUT DUE TO INFECTION. THE LINER AND FEMORAL HEAD WERE REPLACED. THERE WAS NO SURGICAL DELAY. THERE WERE NOT ANY ISSUES WITH THE IMPLANTS THAT WERE TAKEN OUT. DOI: (B)(6) 2024, DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20658383 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO SURGICAL DELAY, B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? - AFFECTED SIDE WAS LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 20421491 ↗