NA 1365-62-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295034070), received between Sep 11, 2017 and Jun 6, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2012, THE PATIENT RECEIVED A RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY TO ADDRESS RIGHT HIP OSTEOARTHRITIS. METAL ON METAL IMPLANTS WERE IMPLANTED. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ALVAL PSEUDOTUMOR, METALLOSIS, OSSEUS BONE EROSIONS, AND OSTEOLYSIS. THE METAL INSERT AND HEAD WERE REPLACED WITH A DUAL MOBILITY LINER CONSTRUCT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, THE PATIENT'S RIGHT HIP WAS REVISED AGAIN TO ADDRESS PURULENT WOUND DRAINAGE, POSSIBLE INFECTION VERSUS ALVAL LESION. CULTURES OBTAINED WERE INCONSISTENT WITH INFECTION, SO THE DIAGNOSIS LEANED IN FAVOR OF ALVAL, SUBSEQUENT TO THE PREVIOUS REVISION. SURGEON REVISED AND REPLACED THE FEMORAL HEAD AND THE DUAL MOBILITY METAL AND POLY LINERS, RETAINING THE ACETABULAR CUP AND FEMORAL STEM. AND EXTENSIVE IRRIGATION AND DEBRIDEMENT WERE PERFORMED. THERE WERE NO COMPLICATIONS. THIS REPORT CAPTURES THE REVISION PROCEDURE ON (B)(6) 2024. THE SECOND REVISION IS CAPTURED ON RELATED COMPLAINT (B)(4). DOI: (B)(6) 2012. DOR: (B)(6) 2024 (ACETABULAR LINER, CUP & FEMORAL HEAD,) RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Osteolysis; Pocket Erosion; Swelling/ Edema

  MAUDE report 22161632 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUSPECTED INFECTION ON LEFT HIP. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17487830 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17479890 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  METAL ON METAL HIP MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT THA WITH METALLOSIS AND PSEUDOTUMOR RESULTING TO HIP PAIN AND ELEVATED METAL IONS. MRI CONFIRMED PSEUDOTUMOR. SLIGHT ELEVATED CELL COUNTS AND SED RATE. ASPIRATION CONFIRMED INFECTION. OPERATIVE NOTE REPORTED SCARRED EXTERNAL ROTATOR AND PURULENT APPEARING FLUID OBVIOUS BROWNISH PSEUDOTUMOR. THERE WAS CORROSION ON THE TRUNNION HOWEVER, STEM WAS WELL FIXED. THERE WAS 2 SCREWS 1 EASILY REMOVE AND THE OTHER ONE IS VERY DIFFICULT TO REMOVE. THERE WAS ACETABULAR MEMBRANE IN THE LINER AND SOME SMALL CAVITARY DEFECTS. DOI: (B)(6) 2007; DOR: (B)(6) 2023; RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17396277 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW PATIENT WAS REVISED BASED ON THE PATHOLOGIC STUDY RESULTS: EXCISION OF BLOOD CLOT, PRE-OP DIAGNOSIS : INFECTION/INFLAMMATION; METALLIC GRAY FEMORAL STEM; METALLIC GRAY ACETABULAR CUP; A METALLIC FEMORAL BALL.

  Patient problems: Anxiety; Cyst(s); Depression; Distress; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Necrosis; Osteolysis; Pain; Pocket Erosion; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16901982 ↗
• InjuryMar 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORD RECEIVED. PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT MALPOSITION AND MULTIPLE DISLOCATIONS. THERE WAS GROSSLY MALPOSITIONED ACETABULAR COMPONENT THAT HAS BECOME WELL FIXATED TO BONE WITH SUPERIOR ACETABULAR WALL LOSS AND POSTEROLATERAL WALL INSUFFICIENCY. DOI: (B)(6) 2010; DOR: (B)(6) 2010; ( LEFT HIP).

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 13770071 ↗
• InjuryFeb 23, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  PATIENT WAS REVISED WAS DUE TO METAL POISONING FROM TOXIC HEAVY METALS RELEASED. RECORDS ALSO ALLEGES PAIN, METAL WEAR, INJURY SCAR TISSUE FORMATION AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6) 2009; DOR: (B)(6) 2021 UNK HIP.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue

  MAUDE report 13584726 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ELEVATED ION COUNT DUE TO A METAL ON METAL CONSTRUCT. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12194113 ↗
• InjuryAug 31, 2020Naturally Worn; Naturally Worn

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESSED INFECTED RIGHT TOTAL HIP ARTHROPLASTY AND EXTENSIVE METALLOSIS/ALVAL REACTION FROM METAL ON METAL ARTICULATION WITH EXTENSIVE TISSUE INFLAMMATION. OPERATIVE FINDINGS THICK PURULENT MATERIAL ANTERIOR AND POSTERIOR HIPS, AS WELL AS OSTEOLYSIS AT THE PROXIMAL FEMUR AND ACETABULUM. ALSO INDICATED PAIN, DISCOMFORT AND SWELLING. A MODERATE AMOUNT OF BURSITIS, SYNOVITIS, BONE LOSS, DEBRIS AS WELL. DOI: (B)(6) 2008. DOR: (B)(6) 2012. (RIGHT HIP).

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Inflammation; Injury; No Code Available; Osteolysis; Pain; Synovitis; Test Result; Unspecified Infection

  MAUDE report 10471118 ↗
• InjuryMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR DISLOCATION. EXTRACTED THE FEMORAL HEAD AND LINER. IMPLANTED A 40MM ARTICULEZE HEAD AND 64 X 40 +4 NEUTRAL CONSTRAINED LINER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9860570 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL IONS. OPERATIVE NOTE REPORTED FIBROUS SCAR TISSUE. THERE WAS CLEAR FLUID NOTED AND SCAR WITHIN THE JOINT AND PSEUDOCAPSULE SCAR. DOI: (B)(6) 2009; DOR: (B)(6) 2014; RIGHT HIP.

  Patient problems: Adhesion(s); Fibrosis; Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9813440 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. UPDATE AD 27 MAR 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF UNF AND MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT REVISED FOR ACUTE PROSTHETIC JOINT INFECTION AND MORBID OBESITY WITH A BMI GREATER THAN 40. OPERATIVE NOTES REPORTED THAT THERE WAS VERY THICK, CLOUDY AND PURULENT SYNOVIAL FLUID. THERE WAS METAL DEBRIS ON THE BACKSIDE OF THE LINER, NO ADVERSE TISSUE REACTION OBSERVED. AN ABSCESS WAS FOUND AROUND THE GLUTEUS MEDIUS. ADDED LAWYER, LAW FIRM, MEDICAL HISTORY, PATIENT DOB, AND EXPIRATION DATES. CORRECTED PATIENT HEIGHT. DOI: (B)(6) 2009; DOR: (B)(6) 2013; RIGHT HIP.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 9574525 ↗
• InjuryOct 31, 2019Corroded; Corroded

  ADDED PATIENT CODES EDEMA AND HYPERSENSITIVITY.

  Patient problems: Adhesion(s); Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 9261066 ↗
• InjuryMay 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR MIGRATION / LOOSENING OF THE ACETABULAR SHELL. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. REVISION OF SHELL, LINER AND HEAD HAS OCCURRED. DOI: (B)(6) 2012; DOE: (B)(6) 2016; DOR: (B)(6) 2016; (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 8660241 ↗
• InjuryApr 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES LOOSENING OF CUP, DISLOCATION AND INFECTION AFTER FIRST REVISION. RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 8539928 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF RECEIVED. PPF ALLEGED ELEVATED METAL IONS. THE METAL LINER, METAL HEAD, AND THE STEM WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATION. DOI: (B)(6) 2009; DOR: (B)(6) 2015, (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8416563 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF STEM, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2008 - DOR: (B)(6) 2010 (RIGHT HIP).

  Patient problems: Deformity/ Disfigurement; No Code Available; Pain; Scarring; Tissue Damage

  MAUDE report 8320622 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO OSTEOLYSIS. DOI: 2007. DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8244807 ↗
• InjuryDec 18, 2018Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PPF ALLEGES DISLOCATION (CLOSED REDUCTION), METAL WEAR AND METALLOSIS.

  Patient problems: Joint Dislocation; Tissue Damage

  MAUDE report 8173580 ↗
• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7893158 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN CAUSED BY METALLOSIS AS A RESULT OF THE METAL-ON-METAL HIP ARTICULATION. DOI: UNKNOWN ; DOR: (B)(6) 2018 ; RIGHT HIP.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7793780 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBJECT ID: (B)(6). CLINICAL NOTIFICATION FOR REVISION DUE TO METALLOSIS WAS RECEIVED. HEAD AND LINER REVISED. DOI: (B)(6) 2009. DOR: (B)(6) 2018. (RIGHT HIP).

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7596895 ↗
• InjuryFeb 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAD A PINNACLE METAL ON METAL HIP ON HIS LEFT SIDE PUT IN BACK IN 2007. THE SURGEON SAID THAT THE PATIENT WAS EXPERIENCING PAIN. HE WANTED TO DO A HEADLINER EXCHANGE. ONCE THE SURGERY STARTED THE SURGEON OPENED AND IN THE CAPSULE THERE WAS A LOT OF DARK FLUID THAT CAME OUT. THE SURGEON SPOKE ABOUT HOW THE TISSUES WERE IN ¿BAD SHAPE¿ ALONG WITH THE PATIENTS ABDUCTORS MUSCLES, AND BONE QUALITY OF HIS FEMUR. HE REMOVED THE METAL LINER VERY EASILY AFTER A COUPLE OF HITS. HE IRRIGATED THE JOINT AND ATTEMPTED TO TRIAL A LINER. HE THEN CHOSE TO JUST PUT IN A REAL LINER IMPLANT WHICH WAS A 40X62 NEUTRAL LINER. HE TRAILED A 40 +5 HEAD AND PUT HIP THRU ROM. HE FELT THE HIP WAS STABLE AND ASKED FOR A CERAMIC TS 40 +5 HEAD IMPLANT. HE THEN CLOSED. DOI: (B)(6) 2007; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Pain

  MAUDE report 7247875 ↗
• InjurySep 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT INITIATED COMPLAINT FORM RECEIVED. IT WAS REPORTED BY THE PATIENT THAT HE HAD BLOOD TEST RAN AND HE DOES IN FACT HAVE ALLERGIES TO CERTAIN METALS. HE IS SUFFERING CHRONIC PAIN, AND IS CONCERNED THAT HE MAY BE ALLERGIC TO THE METALS WHICH MAKE UP HIS HIP IMPLANT.

  Patient problems: Pain

  MAUDE report 6855141 ↗