NA 1365-05-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 10603295032960), received between Nov 20, 2013 and Sep 10, 2026 — classified as 163 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (39 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 165 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Foreign Body Reaction

  MAUDE report 50715733 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50255854 ↗
• InjuryApr 21, 2026Degraded; Naturally Worn

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: METAL WEAR AND FOREIGN BODY REACTION. RETRIEVAL ANALYSIS IDENTIFIED CORROSION OF THE FEMORAL HEAD. THERE IS NO INDICATION THE FEMORAL STEM WAS REVISED.

  Patient problems: Foreign Body Reaction

  MAUDE report 24941212 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS METALLOSIS. EXCHANGED METAL LINER WITH POLY LINER AND TITANIUM SLEEVED CERAMIC HEAD. ORIGINAL IMPLANT DATE MONTH IS UNKNOWN. YEAR OF ORIGINAL IMPLANT WAS 2008. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 24757078 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD OSTEOLYSIS IN THE LEFT HIP, WHICH NECESSITATED A REVISION PROCEDURE USING A RECLAIM APPROACH. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Osteolysis

  MAUDE report 24180370 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP AND UNDERWENT HEAD AND LINER EXCHANGE. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24163153 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE (B)(6), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(4), 70-YEAR-OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 23526141 ↗
• InjuryNov 4, 2025Corroded; Corroded

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH 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 PERIPROSTHETIC FRACTURE. FEMORAL HEAD SHOWED CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 23464882 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTED HIP. THE IMPLANTS WERE REMOVED TO PUT IN A TEMPORARY SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23348150 ↗
• MalfunctionJul 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE HEAD WAS OPENED FOR IMPLEMENTATION BUT DID NOT ENGAGE WITH THE FEMORAL NECK. A NEW HEAD WAS OPENED, WHICH FUNCTION PROPERLY. IT WAS BELIEVED THAT THE FIRST HEAD WAS DEFECTIVE. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 22665331 ↗
• InjuryJul 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. THE SURGEON TOOK OUT PINNACLE LINER AND 40MM 12/14 TAPER HEAD AND REPLACED THE IMPLANTS WITH CONSTRAINED LINER AND TS HEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22382979 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTHMOUTH 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 LOOSE ACETABULAR CUP, OSTEOLYSIS, AND PAIN. AT REMOVAL THE FEMORAL HEAD SHOWED CORROSION.

  Patient problems: Osteolysis

  MAUDE report 21978251 ↗
• InjuryJan 7, 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 METALLOSIS. PATIENT UNDERWENT REVISION HIP SURGERY AND HAD METAL LINER REMOVED AND REPLACED WITH DUAL MOBILITY LINER DUE TO PAIN. MODERATE AMOUNT OF METALLOSIS DISCOVERED DURING SURGERY. NO FURTHER INFORMATION WAS AVAILABLE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 21092818 ↗
• InjuryJan 3, 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 TOTAL HIP. HEAD AND LINER EXCHANGE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21072025 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2024, THE PATIENT HAD A POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATED THAT DUE TO THE OVERLAP OF ABDOMINAL TISSUE, THE INCISION SHOWS A COUPLE AREAS THAT LOOK MOIST AND MACERATED. THE PATIENT WAS TOLD TO TAKE ORAL ANTIBIOTICS AND EDUCATED TO KEEP THE WOUND DRIER BY COVERING WITH A LIGHT GAUZE. ON (B)(6) 2024, THE PATIENT HAD ANOTHER POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATES THAT SHE HAD UNDERGONE AN EXPLORATION AND DEBRIDEMENT OF THE WOUND AND ¿THEN IT WAS JUST A SUPERFICIAL WOUND.¿ SHE CONTINUES TO HAVE A SMALL AREA ON THE MEDIAL SIDE WHICH WAS DEBRIDED ¿A BIT LAST TIME¿ AND IS SLOWLY HEALING. THE PATIENT IS OTHERWISE HEALING AND PROGRESSING WELL.

  Patient problems: Impaired Healing

  MAUDE report 20504682 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT TOTAL HIP REVISION DUE TO FAILED METAL ON METAL LEFT HIP TOTAL REPLACEMENT. OSTEOPHYTES FOUND. DOI: (B)(6) 2010. DOR: (B)(6) 2015. AFFECTED AREA: LEFT HIP.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19620258 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 18 JUN 2024. THIS PC WAS CREATED TO CAPTURE THE ALLEGATION OF ELEVATED COBALT LEVEL ON RIGHT HIP. DOI: (B)(6) 2008. DOR: UNKNOWN. LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 19617948 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17172077 ↗
• InjuryMar 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AS PER SURGEON, PATIENT DISLOCATING. SURGEON REMOVED CUP, HEAD, LINER, SCREW AND RETAINED THE SUMMIT STEM. PART NUMBERS HAD AVAILABLE WERE HARD TO READ. THE SUMMIT STEM : 1570-11-150 L EW9DG1. THE SURGEON PUT IN COMPETITOR CUP AND NEW 12/14 ARTICULATE 28 +5 COCR HEAD. DOI: (B)(6) 2011. DOR: (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16495099 ↗
• InjuryFeb 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HIS HIP REPLACED ABOUT 10 YEARS AGO. HE RECENTLY HAD A DISLOCATION. SO THE SURGEON DECIDED TO DO A HIP REVISION AND INSERT A CONSTRAINED LINER. DOI: 10 YEARS AGO. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16385762 ↗
• InjuryDec 8, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: 15 SEP 2022. (LEFT HIP). TREATMENT: REVISION; HAND AND LINER REVISED.

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

  MAUDE report 15940770 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEPTIC HIP APPROXIMATELY 12 YRS POST PRIMARY IMPLANTATION. I&D W/HEAD LINER EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15657393 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PINNACLE MOM HIP REPLACEMENT. PATIENT BEGAN EXPERIENCING NUMBNESS IN HIS FEET. SURGEON TESTED FOR METAL ION LEVELS AND STATED ONE WAS ELEVATED WHILE THE OTHER WAS IN NORMAL RANGES. THE DECISION WAS MADE TO DO A HEAD LINER EXCHANGE FROM MOM TO CERAMIC ON POLY. A HEAD WAS REMOVED ALONG WITH PINNACLE MOM LINER. SURGEON REPLACED WITH A CERAMIC AND A LINER UNEVENTFULLY. NO PATIENT HARM WAS NOTED DURING THE PROCEDURE. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT HIP.

  Patient problems: Metal Related Pathology; Numbness

  MAUDE report 15249658 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL HIP, PAINFUL ULTAMET METAL-ON-METAL BILATERAL TOTAL HIP REPLACEMENTS. THE PRIMARY PROCEDURES WERE PERFORMED IN 2008 AND 2009. NO ADDITIONAL INFORMATION IS AVAILABLE. NO SURGICAL DELAY. DOI: 2008, 2009. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 15240626 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SOLUTION OR AML SUBSIDED EARLY POST OP. FEELING UNSTABLE AND SHORT ON HIS LEG. NO SIGNS OF METALOSYS IN THE TISSUES OR ELEVATED MARKERS. ALSO HAS END OF STEM THIGH PAIN. DOI: (B)(6) 2008, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain; Physical Asymmetry

  MAUDE report 14602014 ↗