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SUMMIT 1570-12-110Recalls & reported problems

Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER TAPERED w/DUOFIX HA SIZE 5 HI 145mm · Class 2 · Implant

Quick summary

This DePuy Summit hip implant is a metal hip stem used in hip replacement surgery. The 53 reports mostly describe hip pain, discomfort and tissue damage, along with claims of metal wear and metal poisoning in the blood, with some patients needing revision surgery; many also mention corroded or degraded parts. There are 51 reports of injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
53
Deaths reported
0
Injuries reported
51
Recalls naming it
0

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295060161), received between Jun 22, 2017 and Dec 12, 2024 — classified as 51 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (12 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem32
  • Biocompatibility12
  • Appropriate Device Problem Term/Code Not Available7
  • Degraded7
  • Corroded5
  • Insufficient Device Problem Information3
  • Loss of Osseointegration2
  • Migration1

Patient problems

  • Pain40
  • Test Result31
  • No Code Available28
  • Tissue Damage17
  • Discomfort15
  • Foreign Body Reaction15
  • Hypersensitivity/Allergic reaction14
  • Limited Mobility Of The Implanted Joint9

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 12, 2024Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED THAT PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT HIP.

    Patient problems: Inadequate Osseointegration; Limb Fracture

    MAUDE report 20916093 ↗
  • InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REMOVING OLD ASR HIP IMPLANTS FROM PATIENT DUE TO PAIN AND HIGH METAL LEVELS IN BLOOD, SUSPECTED METALOSIS. DOI: 2010. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

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

    MAUDE report 17458876 ↗
  • InjuryJan 6, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

    ASR XL LITIGATION COMPLAINT RECEIVED AD 19 DEC 2022. PATIENT WAS REVISED DUE TO PAIN, DISCOMFORT, INCREASE METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM, PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT AND ECONOMIC DAMAGES INCLUDING MEDICAL EXPENSES. DOI: (B)(6) 2008. DOR: (B)(6) 2022. LEFT HIP.

    Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Unspecified Tissue Injury

    MAUDE report 16111486 ↗
  • InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT ALLEGES SIGNIFICANT PAIN, INJURY CAUSED BY METALLOSIS, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, AND LIMITATION OF DAILY ACTIVITIES. DAMAGES WERE DUE TO THE DEFECTS AND UNREASONABLE DANGER FROM THE SYSTEM. MOREOVER, PATIENT SUFFERED INJURY TO HIS MUSCLE AND TISSUE, ADDITIONAL SCAR TISSUE FORMATION, PSEUDOTUMOR EXCISION AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY. IN ADDITION, PATIENT INCURRED LOST EARNING POTENTIAL. EXPERIENCED AND SUFFERED MENTAL PAIN, EMOTIONAL TRAUMA AND DISTRESS AND IS LIKELY TO SUFFER CONTINUED BOTH INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING, PHYSICAL DISABILITY AND PAST PRESENT AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE AND PHARMACEUTICAL EXPENSES AND OTHER RELATED DAMAGES. DOI: (B)(6) 2010. DOE/DOR: (B)(6) 2022. AFFECTED SIDE : UNKNOWN.

    Patient problems: Adhesion(s); Cyst(s); Distress; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

    MAUDE report 15889683 ↗
  • InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM TOXIC HEAVY METAL RESULTING TO INJURIES, HIP PAIN, METALLOSIS, METAL WEAR AND LIMITED ADL. PLAINTIFF ALSO SUFFERED EMOTIONAL TRAUMA AND DISTRESS. PLAINTIFF SUFFERED SUBSEQUENT DISLOCATION POST REVISION LEFT HIP. DOI: (B)(6) 2008; DOR: (B)(6) 2022; LEFT HIP.

    Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Physical Asymmetry; Scar Tissue; Synovitis; Unspecified Tissue Injury

    MAUDE report 15887528 ↗
  • InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT HAS ADVISED THEY HAD A A CUP AND BALL IMPLANTED INTO THEIR HIP IN 2007 AND BELIEVE THAT THEY HAVE HEAVY METAL POISONING WHICH IS CAUSING BAD HEADACHES.

    Patient problems: Headache; Metal Related Pathology

    MAUDE report 15609448 ↗
  • InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    LITIGATION COMPLAINT RECEIVED AD 7 JUL 2022. CLAIM LETTER ALLEGES BREATHING DIFFICULTIES, VERY HIGH LEVELS OF METAL TOXICITY. PATIENT WAS REVISED WAS DUE TO METALLOSIS, A TUMOR, CYSTS AND NECROTIZING TISSUE. DOI: 18 YEARS AGO. DOR: (B)(6) 2022. UNK HIP.

    Patient problems: Anxiety; Cyst(s); Deformity/ Disfigurement; Distress; Dyspnea; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Limb Fracture; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Tissue Injury

    MAUDE report 15085480 ↗
  • InjuryJun 30, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

    PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RESULTING TO MUSCLE, TISSUE AND BONE INJURY, METALLOSIS, METAL WEAR, SCAR TISSUE FORMATION, PAIN AND LIMITED ADL. ALSO SUFFERED EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2009; DOR: UNREVISED ; LEFT HIP.

    Patient problems: Adhesion(s); Depression; Distress; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

    MAUDE report 14875547 ↗
  • InjuryJun 30, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

    PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RESULTING TO MUSCLE, TISSUE AND BONE INJURY, METALLOSIS, METAL WEAR, SCAR TISSUE FORMATION, PAIN AND LIMITED ADL. ALSO SUFFERED EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2010; DOR: (B)(6) 2021; RIGHT HIP.

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

    MAUDE report 14874975 ↗
  • MalfunctionOct 28, 2020Migration; Migration

    CLINICAL ADVERSE EVENT RECEIVED FOR EARLY SUBSIDENCE FOLLOWING TOTAL HIP ARTHROPLASTY: ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN, DATE OF EVENT (ONSET): (B)(6) 2015, (RIGHT HIP). TREATMENT: NONE (2 MM SUBSIDENCE IS NOT PROGRESSIVE).

    Patient problems: No Code Available

    MAUDE report 10747604 ↗
  • InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN, CELLULITIS, FEVER, CHILLS, NOTED ABSCESS IN THE CT SCAN AND PERIPROSTHETIC JOINT INFECTION. OPERATIVE NOTE REPORTED BIOFILM FORMATION IN THE HEAD. DOI: (B)(6) 2019; DOR: (B)(6) 2019: RIGHT HIP.

    Patient problems: Cellulitis; Fever; No Code Available; Pain; Unspecified Infection

    MAUDE report 10094928 ↗
  • InjuryMar 20, 2020Naturally Worn; Naturally Worn

    AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. PATIENT ALLEGES RECURRENT DISLOCATION, INSTABILITY, SUBLUXATION, PAIN, AND TENDERNESS DURING PALPATION. THE HEAD AND NECK WERE NOTED. THERE WAS DEBRIS UNKNOWN AS TO EXACTLY WHAT THIS WAS. DOI: (B)(6) 2009; DOR: (B)(6) 2010 (RIGHT HIP).

    Patient problems: Discomfort; No Code Available; Pain

    MAUDE report 9861735 ↗
  • InjuryMar 19, 2020Corroded; Corroded

    AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED LEFT HIP TOTAL ARTHROPLASTY WITH PAIN WHICH EVENTUALLY BECAME DISABLING AND AFFECTED THE PATIENTS ACTIVITIES OF DAILY LIVING AND HISTORY OF TWO HIP DISLOCATIONS WHICH WERE CLOSED REDUCED. HIP ASPIRATION WAS ALPHA DEFENSIN POSITIVE WITH CELL COUNT OF 6000 AND 66% NEUTROPHILS. CULTURES HAD NO GROWTH. MRI SHOWED FLUID COLLECTION WITH SUSPICION OF PSEUDOTUMOR. INTRAOPERATIVELY, AFTER INCISION, THERE WAS A LARGE GUSH OF CLEAR, NON-TURBID SYNOVIAL FLUID, A LARGE MEMBRANE WHICH WAS EXCISED, HYPERTROPHIC SYNOVIUM AND MILD DARK STAINING ON THE TRUNNION. DOI: (B)(4) 2009, DOR: (B)(4) 2017, (LEFT HIP).

    Patient problems: Edema; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; Local Reaction; No Code Available; Pain

    MAUDE report 9856783 ↗
  • InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT COMPLAINTS OF RIGHT HIP PAIN. THE PATIENT WAS THEN REVISED FOR FAILED METAL-ON-METAL LEFT TOTAL HIP ARTHROPLASTY, ELEVATED SYSTEMIC METAL ION LEVELS, MRI CONSISTENT WITH ALTR. OPERATIVE NOTES REPORTED THAT THERE WAS BLACKENED OILY MATERIAL AND FLUID FOUND AROUND MORE THAN 500ML. THE ABDUCTOR MUSCLE WERE FOUND IN POOR CONDITION AND DETACHED FROM THE ANTERIOR ASPECT OF THE GREATER TROCHANTER. FURTHER DEBRIDEMENT OF THE ENTIRE EFFECTIVE JOINT SPACE WAS CARRIED OUT AND ALL ABNORMAL-APPEARING TISSUE, SCAR, AND MEMBRANES WERE CLEARED. A NUMBER OF HETEROTOPIC BONE ISLANDS WERE IDENTIFIED IN THE ABDUCTOR MUSCLES. THE SIGNIFICANT VOLUME OF INFLAMMATORY BLACKENED TISSUE WAS EXCISED FROM THE ENTIRE INTRACAPSULAR AND AFFECTED JOINT SPACE. RADICAL DEBRIDEMENT OCCURRED IN THE POSTERIOR RECESSES AND DOWN INTO THE ISCHIUM WHERE THERE WAS A LARGE OSTEOLYTIC LESION. OPERATIVE FINDING REPORTED THAT THERE WAS A SEVERE METAL REACTION SURROUNDING THE JOINT. THE ENTIRE PROXIMAL FEMUR WAS OSTEOLYTIC AND THE BONE WAS ABSENT SURROUNDING THE PROXIMAL PORTION OF THE STEM. IT WAS ALSO MENTION THAT RADICAL DEBRIDEMENT OF FLORID METAL-ON-METAL RE

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

    MAUDE report 9831828 ↗
  • InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AFTER REVIEW OF MEDICAL RECORDS IT WAS INDICATED THAT PATIENT CT SCAN HAD REVEALED A LARGE PELVIC ABSCESS WITH ASPIRATION DEMONSTRATING GRAM POSITIVE COCCI. THE PATIENT WAS THEN REVISED FOR PERIPROSTHETIC LEFT TOTAL HIP INFECTION AND METALLOSIS REACTION OF THE LEFT TOTAL HIP FROM A METAL ON METAL PROSTHESIS. OPERATIVE NOTES REPORTED PURULENT DISCHARGE WERE ENCOUNTERED. THERE WAS METALLOSIS AROUND THE PSUEDOCAPSULE. THERE WAS SOME TRUNNIONOSIS ON THE TRUNNION AND THERE WAS SOME LYSIS AROUND THE ACETABULUM. DOI: (B)(6) 2006; DOR: (B)(6) 2018.

    Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Unspecified Infection

    MAUDE report 9805282 ↗
  • InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    LITIGATION RECORD RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY REPORTED LITIGATION ALLEGES INJURY AND ECONOMIC LOSS, EXCESSIVE LEVELS OF CHROMIUM AND COBALT, PAIN, SUFFERING, EMOTIONAL DISTRESS.

    Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; No Code Available; Pain; Test Result; Unspecified Infection

    MAUDE report 9637616 ↗
  • InjuryJan 28, 2020Degraded; Degraded

    UNF AND MEDICAL RECORDS RECEIVED. THERE WERE NO ALLEGATION REPORTED FROM UNF. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RIGHT HIP ADVERSE LOCAL TISSUE REACTION DUE TO METAL ON METAL TOTAL HIP REPLACEMENT. INDICATION NOTE REPORTED WEAKNESS, COBALT LEVEL 140 AND CHROMIUM LEVEL 100, AND ON X-RAY THERE WAS PROTRUSION OF THE SHELL. OPERATIVE NOTE REPORTED SIGNIFICANT AMOUNT OF NECROTIC TISSUE THAT HAD CORROSION, ABDUCTOR TISSUE LOSS, AND THERE WAS CORROSION ON THE TAPER, CORROSION AT THE EDGE OF THE SHELL AND LINER, AND THE LINER APPEARED COLD WELDED TO THE SHELL, BONE LOSS FROM THE SHELL REMOVAL, PSEUDOTUMOR AND CYSTS. DOI: (B)(6) 2008; DOR: (B)(6) 2019 (RIGHT HIP) FIRST REVISION.

    Patient problems: Cyst(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Test Result; Tissue Damage; Weakness

    MAUDE report 9636444 ↗
  • InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS. DOI (B)(6) 2011; DOR (B)(6) 2016; (RIGHT HIP).

    Patient problems: No Code Available; Test Result

    MAUDE report 9152752 ↗
  • InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PFS REPORTED DISLOCATION, METAL DEBRIS, GRAM STAIN AND CULTURE, PAIN, AND LOUD SQUEAKING NOISE. THE REVISION SURGICAL REPORT NOTED DISPLACED LINER, PAIN AND POPPING AT PHYSICAL THERAPY THAT WENT AWAY, METAL DEBRIS IN THE SOFT TISSUES, GEAR OIL TYPE FLUID FROM THE CAPSULE, LINER WAS LOOSE BUT STILL WITHIN CUP BUT ROCKING BACK AND FORTH AND HAD A CRACK AND LARGE FRAGMENT ON IT, AND THE FEMORAL HEAD WAS BURNISHED. NO PART/LOT STICKERS OR NUMBER PROVIDED. PATIENT HARMS UPDATED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METALLOSIS AND ELEVATED METAL IONS. ADDED LAW FIRM, SURGEON, HOSPITAL, PRODUCT DETAILS, PATIENT HARM AND NEW IP(STEM). DOI: (B)(6) 2012 - DOR: (B)(6) 2013 (LEFT HIP).

    Patient problems: Foreign Body Reaction; No Code Available; Pain; Test Result

    MAUDE report 8968075 ↗
  • InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    COMPLAINT DESCRIPTION: PATIENT WAS REVISED. REASON FOR REVISION NOT PROVIDED. UPDATE REC¿D 01/27/2017 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALSO ALLEGES THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT. UPDATE AD 8 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS AND STERILE ABSCESS. REVISION NOTE REPORTED OF MILKY FLUID WITHIN THE HIP JOINT. REVISION NOTE HAS NO INFECTION REPORTED. THE PATIENT HARM AND PRODUCT EXPERIENCE CODE WERE UPDATED AND ADDED LAWYER. THE STEM WAS ADDED TO THE IMPACTED PRODUCT DUE TO THE ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2014, (LEFT HIP). PLEASE SEE (B)(4) FOR THE RIGHT HIP REVISION.

    Patient problems: Abscess; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

    MAUDE report 8952024 ↗
  • InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PPF AND STICKER SHEET RECEIVED. PPF ALLEGES INFECTION AND ELEVATED METAL IONS AFTER FIRST REVISION. LINER IS NON-DEPUY. DOI: (B)(6) 2008 (CUP AND STEM). DOI: (B)(6) 2010 (FEMORAL HEAD). DOR: (B)(6) 2010 LEFT HIP.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 8889341 ↗
  • InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN IN HER GROIN, BUTTOCKS, AND LEG, AS WELL AS NUMBNESS AND DIFFICULTY SITTING, WALKING, AND LAYING. PPF ALLEGES ELEVATED METAL IONS, METALLOSIS, METAL WEAR AND LOOSENING OF CUP. DOI: (B)(6) 2008, DOR: (B)(6) 2012 (RIGHT HIP).

    Patient problems: Foreign Body Reaction; Hypoesthesia; Loss of Range of Motion; No Code Available; Pain; Test Result

    MAUDE report 8883714 ↗
  • InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED FOR INFECTION, TEMPORARY IMPLANTS WERE PLACED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT HIP.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 8871231 ↗
  • InjuryJul 29, 2019Degraded; Degraded

    MEDICAL RECORD RECEIVED. IT WAS STATED THAT THE PATIENT HAS VERY MILD LYSIS. THERE IS MILD HETEROTOPIC FORMATION OF BONE.

    Patient problems: Cyst(s); Discomfort; Foreign Body Reaction; No Code Available; Osteolysis; Pain; Test Result

    MAUDE report 8837286 ↗
  • InjuryMay 2, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM EROSION, PAIN, METALLOSIS AND FLUID BUILD-UP. UPDATE THE REVISION OPERATIVE NOTE INDICATED A MALPOSITIONED CUP AND ONE SCREW THAT WASN¿T FULLY SEATED. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2013, (LEFT HIP).

    Patient problems: No Code Available; Pain; Pocket Erosion; Test Result

    MAUDE report 8574539 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.