NA 1365-04-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10603295032946), received between Aug 4, 2017 and Sep 2, 2026 — classified as 93 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 95 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Naturally Worn

  Patient problems: Metal Related Pathology

  MAUDE report 50572739 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PERSISTENT INFECTION IN THEIR LEFT HIP. JOINT WAS WASHED OUT AGAIN AND THE HEAD AND LINER WERE GOING TO BE EXCHANGED, HOWEVER THE CUP CAME LOOSE WHEN TRYING TO EXTRACT THE LINER. THUS, THE HEAD, LINER AND CUP WERE ALL EXCHANGED FOR A MODULAR UNIPOLAR BALL. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24097135 ↗
• 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), 73-YEAR-OLD FEMALE. PATIENT EXPERIENCED ADVERSE TISSUE REACTION, ALLERGY/HYPERSENSITIVITY REACTION REQUIRING TROCHANTERIC DEBRIDEMENT. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2022.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 23525781 ↗
• InjuryAug 28, 2025Degraded; Degraded

  ON (B)(6) 2010, PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT. ON (B)(6) 2023, PATIENT UNDERWENT ASPIRATION RIGHT HIP DUE TO RIGHT PAINFUL TOTAL HIP ARTHROPLASTY. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO ADVERSE METAL REACTION AND ELEVATED COBALT LEVELS. THE PATIENT HAD INCREASE FATIGUE AND DEPRESSION THEN DEVELOPED TREMORS AND EVENTUALLY MORE PAIN. DURING OPERATIONS, RUSTY COLORED FLUID UPON INCISION INTO THE CAPSULE ALONG WITH NECROTIC RUSTY STAINED TISSUE ON THE INSIDE OF THE CAPSULE WERE FOUND. FURTHERMORE, A FAIR AMOUNT OF BONE LOSS WAS NOTED AND BONE WAS EXTREMELY THIN AND RIDGE COULD BE PALPATED. IT WAS ALSO OBSERVED THAT THERE WAS CORROSION OCCURRING AT THE TAPER JUNCTION IN THE FEMORAL NECK. DOI: (B)(6) 2010 DOR: (B)(6) 2023 AFFECTED SITE: RIGHT HIP.

  Patient problems: Bone Notching; Cramp(s) /Muscle Spasm(s); Depression; Fatigue; Foreign Body Reaction; Metal Related Pathology; Necrosis; Pain

  MAUDE report 22919381 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2008. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22337855 ↗
• MalfunctionMay 8, 2025Corroded; Corroded

  (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: REMOVAL OF PROSTALAC SPACER AFTER INFECTION TREATMENT. REIMPLANTATION OF FINAL IMPLANTS. AT REMOVAL THE FEMORAL HEAD SHOWED CORROSION. AT REMOVAL THE ACETABULAR LINER SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 21986193 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BILATERAL PINNACLE METAL ON METAL THAS THAT DID WELL FOR APPROXIMATELY TWENTY YEARS. THEY WERE REVISED DUE TO INFECTION WITH A WASHOUT AND DEBRIDEMENT. SURGEON CHANGED TO POLY LINERS AND TS CERAMIC HEADS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21211345 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT ACETABULAR LINER REVISION DUE TO PRIOR TESTING THAT INDICATED ELEVATED METAL IONS. METAL LINER WAS REMOVED AND REPLACED WITH A PINNACLE 36 MM X 58 NEUTRAL ATTUNE POLY LINER. NO OTHER INFORMATION IS AVAILABLE OR ANY ISSUES OF INSTABILITY NOTED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 20191857 ↗
• InjuryAug 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED DUE TO CUP IMPLANTED VERTICALLY. S/N CUP WAS IMPLANTED WITH OUR HEAD. NO SURGICAL DELAY. NO OTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20055320 ↗
• InjuryJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. STEM, HEAD, AND LINER WERE REMOVED AND REPLACED WITH DEPUY LINER. STEM AND HEAD WERE REPLACED WITH COMPETITOR'S IMPLANTS. NO LOSS OF TIME. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19701870 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. PLAINTIFF HAD A TOTAL HIP ARTHROPLASTY ON APRIL 8, 2008 DUE TO SEVERE DEGENERATIVE JOINT DISEASE. PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY REVISION ON (B)(6) 2023 DUE TO SIGNIFICANT OSTEOLYTIC MATERIAL NOTED THROUGHOUT THE PROXIMAL FEMUR, GRAYISH TYPE FLUID NOTED THROUGHOUT SOFT TISSUE. PLAINTIFF UNDERWENT WORKUP WHICH SHOWED THAT THERE WAS LOOSENING OF THE FEMORAL STEM. THIS IS A METAL ON METAL ARTICULATION AND COBALT AND CHROMIUM BLOOD LEVELS WERE NOTED TO BE ELEVATED AND RECOMMENDED THAT HE PROCEED WITH REVISION OF THE FEMORAL COMPONENT AND REMOVAL OF THE ACETABULAR LINER TO CONVERT TO A DUAL MOBILITY TYPE CONSTRUCT. PLANS WERE THEN MADE TO PROCEED WITH REVISION OF ACETABULUM AND FEMUR. DOI: (B)(6) 2008. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis; Unspecified Tissue Injury

  MAUDE report 19527401 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, HEAD AND LINER WERE EXCHANGED. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19326049 ↗
• InjuryApr 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19202255 ↗
• InjuryFeb 27, 2024Naturally Worn; Naturally Worn

  UPDATE AD 15 FEB 2024 MEDICAL RECORDS RECEIVED. PATIENT UNDERWENT REVISION DUE TO ELEVATED COBALT LEVELS- REMOVAL OF COBALT CHROME HIP BALL AND COBALT CHROME ACETABULAR LINER. SLIGHTLY CLOUDY YELLOW SYNOVIAL FLUID IN MODERATE QUANTITY, ASSOCIATED WITH REACTIVE, TAN-COLORED SYNOVITIS CONSISTENT WITH METALLOSIS, TRUNNION CORROSION IDENTIFIED. THIS INCLUDED SMALL THIN PIECES OF DARK STAINED MATERIAL ADHERENT TO THE BASE OF THE TRUNNION. PERIPROSTHETIC OSTEOLYSIS AND WEAR OF ARTICULAR BEARING SURFACE. FOR PLACEMENT WITH HIGHLY CROSS-LINKED POLYETHYLENE LINER AND REVISION OF CERAMIC HIP BALL. DOI: (B)(6) 2009. DOR: (B)(6) 2021. AFFECTED SIDE : LEFT HIP. THIS IS A BILATERAL HIP ARTHROPLASTY. A LINK OF (B)(4).

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 18787232 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. WASH OUT WAS DONE. DOI: UNKNOWN. DOR: (B)(3) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18435131 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNSTABLE HIP. DOI: (B)(6) 2012. DOR:(B)(6) 2023. AFFECTED SIDE: RIGHT HIP. ADDITIONAL EVENT INFORMATION STATES: THERE WAS NO SURGICAL DELAY. INSTABILITY WAS NOT DUE TO POLY WEAR. THERE WAS NO EVIDENCE OF MALPOSITIONED COMPONENTS. THERE WERE NO UNDERSIZED COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 18320292 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TOTAL HIP INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17797533 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 16787413 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A 40 ULTIMATE XL METAL ON METAL, HAD ELEVATED METAL IONS, PAIN AND OSTEOLYSIS AROUND HIS STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2008, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 16712433 ↗
• InjuryMar 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATED RIGHT TOTAL HIP. REVISED TO CONSTRAINED LINER. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2010, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16551738 ↗
• InjuryJul 22, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING DUE TO ELEVATED METAL IONS RESULTING TO INJURY TO THE MUSCLES, TISSUES, METALLOSIS, SCAR TISSUE FORMATION, LIMITED ADL, EMOTIONAL TRAUMA, DISTRESS AND PAIN. DOI: (B)(6) 2009, DOR: (B)(6) 2022, HIP UNKNOWN.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Depression; Discomfort; Distress; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15084484 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF RIGHT TOTAL HIP, SUMMIT STEM, 40 -2 HEAD AND 40 METAL ON METAL LINER WITH 60 PINNACLE SECTOR CUP. ONLY THE SUMMIT STEM WAS RETAINED. CUP, LINER, HEAD, BONE SCREW WERE EXPLANTED. A BIOMET CUP WAS PUT IN WITH BIOMET LINER. 40 +8.5 CERAMIC TS HEAD WAS PLACED ON SUMMIT STEM. EXPLANATION FOR REVISION WAS NOT PROVIDED TO THE REPRESENTATIVE. IT WAS NOT NOTED AT THE TIME OF SURGERY THAT THERE WAS A DEFICIENT PRODUCT. IT WAS NOTED BY THE SURGEON IT IS A METAL ON METAL LINER. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Cyst(s); Fever; Foreign Body Reaction; Metal Related Pathology; Neuralgia; Pain; Swelling/ Edema

  MAUDE report 14734520 ↗
• InjuryNov 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT HAS A RIGHT TOTAL HIP THAT IS DISLOCATING. THE SURGEON DID A LINER AND HEAD EXCHANGE TO STABILIZE IT. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12828033 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS FROM (B)(6) 2021 NOTE THAT THE PATIENT HAS SEVERE LEFT HIP PAIN AFTER A STUMBLE AND FALL. THE IMPLANTS CONSISTED OF A CORAIL UNCEMENTED FEMORAL STEM, AND A PINNACLE CUP WITH A METAL ON METAL BEARING SURFACE. DOI: (B)(6) 2010. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Osteolysis; Pain

  MAUDE report 12325339 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPETITOR THA DONE AT A DIFFERENT FACILITY IN 2016. A DEPUY THA WAS DONE IN 2018. THE PATIENT STATES SHE HAS HAD CONSTANT PAIN AND DISCOMFORT SINCE THE HIP WAS IMPLANTED IN 2018. IT WAS DETERMINED THAT THE CUP NEEDED TO BE MEDIALIZED, AND A SMALLER HEAD/LINER CONSTRUCT WOULD BE IMPLANTED. THE PATIENT HAS NO RELATIVE COMORBIDITIES, FALLS, OR TRAUMAS. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2018, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Pain

  MAUDE report 11796880 ↗