SUMMIT 1570-12-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295060178), received between Jul 27, 2017 and May 11, 2023 — classified as 49 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DISLOCATION. THE STEM, DUAL MOBILITY LINER & HEAD WERE REVISED. RECLAIM & PINNACLE CONSTRAINED LINER WERE IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 16910193 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION X-RAY RESULTS SHOWED BILATERAL OSTEOARTHRITIS, SEVERE ON THE LEFT. CYSTIC CHANGES OF THE ACETABULUM AND FEMORAL HEAD BILATERALLY. MILD HETEROTOPIC OSSIFICATION LEFT HIP AREA, PRESENCE OF UNSPECIFIED ARTIFICIAL HIP JOINT. X-RAY RESULT SHOWED BILATERAL LEG WEAKNESS. (B)(6) 2010 PENETRATION FRACTURE AT POSTERIOR CORTEX NONDISPLACED CRACK FRACTURE OF THE CALCAR AREA. PAST BILATERAL TOTAL HIP REPLACEMENT, CURRENT PAIN ON THE LEFT SIDE WITH NEW LUMP. (B)(6) 2022: IMPRESSION SHOWS: PELVIC AND OSTEOLYSIS AND CHRONIC PAIN, POSSIBLE INFECTION, SWELLING, SIGNIFICANT HO BUT IMPLANTS USED DURING REVISION WERE COMPETITORS. THE PATIENT WAS REVISED DUE TO FAILED LEFT TOTAL HIP ARTHROPLASTY, OPEN REDUCTION AND INTERNAL FIXATION PROXIMAL FEMUR FRACTURE, METALLOSIS, OSTEOLYSIS, AND PSEUDOTUMOR. OPERATIVE NOTES INDICATED BONY DESTRUCTION AND EVIDENT ON THE PROXIMAL FEMUR AS WELL AS A SOFT TISSUE DESTRUCTION. THERE WAS SIGNIFICANT NECROTIC-APPEARING TISSUE. THERE WERE SIGNIFICANT BONY EROSIONS AND THE TROCHANTER WAS FOUND TO BE ERODED POSTERIORLY AND HAVE SMALL FRACTURE.

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

  MAUDE report 16902009 ↗
• InjuryOct 12, 2022Osseointegration Problem; Osseointegration Problem

  LITIGATION RECORD RECEIVED. PATIENT ALLEGES PAIN AND SUFFERING, SERIOUS BODILY INJURIES, AND ECONOMIC LOSS. DOI: (B)(6) 2007, DOR: (B)(6) 2019, (RIGHT HIP).

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Cyst(s); Fatigue; Fibrosis; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Limb Fracture; Metal Related Pathology; Necrosis; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15587416 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. PATIENT ALLEGES THAT AFTER THE REVISION PATIENT HAD EXPERIENCED PAIN, STIFFNESS, AND SORENESS IN THE RIGHT HIP AREA, METAL STAINING THROUGHOUT THE TISSUE AND HAD A PSEUDOTUMOR FORMATION IN THE POSTERIOR AND INFERIOR CAPSULAR AREAS THAT REQUIRED REMOVAL, AND PELVIC BONE DETERIORATED. PATIENT HAD ANXIETY, FEAR, AND METALLOSIS. DOI: (B)(6) 2021 - DOR: UNKNOWN (RIGHT HIP).

  Patient problems: Anxiety; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Unspecified Tissue Injury

  MAUDE report 15535804 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED DUE TO LOCAL ADVERSE TISSUE REACTION SECONDARY TO METALLOSIS. PATIENT HAD ELEVATED METAL ION LEVELS AND EXPERIENCED PAIN. REVISION NOTES STATED THAT A DARK TEA-COLORED THIN SYNOVIAL FLUID WAS ENCOUNTERED. THERE WAS SMALL AMOUNT OF TRUNNIONOSIS AT THE BASE OF THE TRUNNION. THE ACETABULAR COMPONENT WAS NOTED TO HAVE A STEP-OFF ON THE INNER DIAMETER RESULTING IN A VERY SHARP EDGE. CUP WAS REMOVED WITH A VERY MINIMAL BONE LOSS. BONE SCAN OF THE BILATERAL HIPS DONE (B)(6) 2021 STATED INCREASED PERIPROSTHETIC TRACER UPTAKE GREATEST ALONG THE PROXIMAL FEMORAL COMPONENT AT THE GREATER TROCHANTER TO LESSER TROCHANTER, THERE IS POSSIBLE HARDWARE LOOSENING. MRI OF LEFT HIP LAST (B)(6) 2021 STATED THAT THERE IS NO FRACTURE OR DEFINITE LOOSENING SEEN. THERE MAYBE PERIPROSTHETIC EFFUSION NOTED. LABORATORY RESULT LAST (B)(6) 2021 FOR CHROMIUM WAS 3NG/ML AND COBALT WAS 6.9NG/ML. DOI: (B)(6) 2009. DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Numbness; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 13453589 ↗
• InjuryOct 14, 2021Naturally Worn; Naturally Worn

  ASR CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILURE OF RIGHT TOTAL HIP REPLACEMENT WITH METALLOSIS. OPERATIVES NOTES INDICATED THAT PATIENT HAD PAIN AND SWELLING SEVERAL YEARS. COBALT AND CHROMIUM LEVELS WERE ELEVATED. A LARGE AMOUNT OF FLUID IN THE JOINT WAS NOTED TO DISTEND THE CAPSULE BUT THE SURROUNDING MUSCLE AND SOFT TISSUE APPEARED HEALTHY. THERE WAS SOME VISIBLE BUT MILD METALLIC TISSUE STAINING AND THE SYNOVIAL FLUID WAS CLEAR WAS CLOUDY. A MILD FRETTING OF THE TRUNNION WAS NOTED. CUP WAS REMOVED WITH A MINIMUM OF ACETABULAR BONE LOSS. DOI: (B)(6) 2008; DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12632019 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 12415514 ↗
• InjuryAug 4, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE SURGEON STATES PATIENT HAS AN ASR AND IS HAVING INCREASED PAIN, ELEVATED METAL IONS, SIGNIFICANT OSTEOLYSIS, AND NO INSTABILITY. THE SURGEON REVISED TO PINNACLE CUP, POLY LINER, AND A CERAMIC HEAD. TO ANSWER THE QUESTION BELOW, NO INSTRUMENTS WERE BROKEN IN CASE, THEREFORE NO INSTRUMENTS WERE REMOVED FROM THE PATIENT." DOI: (B)(6) 2006, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Emotional Changes; Erythema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain

  MAUDE report 12278533 ↗
• InjuryOct 16, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD HIS PRIMARY POROUS STEM REMOVED DUE TO BEING IN VARUS AND MALPOSITIONED AND WAS REVISED TO A CEMENTED SUMMIT SIZE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10690371 ↗
• InjuryOct 6, 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 PATIENT WAS REVISED TO ADDRESSED PAIN, PSEUDOTUMOR, ELEVATED COBALT AND CHROMIUM LEVELS AND TRUNNIONOSIS. DOI: (B)(6) 2009, DOR: (B)(6) 2019, RIGHT HIP.

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

  MAUDE report 10638066 ↗
• InjuryAug 26, 2020Degraded; Degraded

  UPDATE AD 14 SEP 2020. LITIGATION RECORDS RECEIVED. LITIGATION RECORDS ALLEGES, CORROSION, FRICTION WEAR, TOXIC COBALT CHROMIUM METAL DEBRIS, PAIN, DIFFICULTY IN AND AROUND HER IMPLANT, EXTENSIVE TISSUE DAMAGE AND METALLOSIS AS WELL AS SUFFERING, METAL ANGUISH, DISTRESS, DISFIGUREMENT AND PHYSICAL IMPAIRMENT.

  Patient problems: Distress; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 10454876 ↗
• InjuryMar 30, 2020Migration; Migration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD THE PATIENT WAS REVISED TO ADDRESS LEFT PERIPROSTHETIC FEMUR FRACTURE. THE SURGEON OPTED TO PROCEED WITH OPEN REDUCTION INTERNAL FIXATION LEFT FEMUR FRACTURE AND REVISION OF FEMORAL COMPONENT. ON PATIENT'S HISTORY OF ILLNESS, SHE WAS EXPERIENCING PAIN, DISCOMFORT, SUBTLE SHORTENING OF THE LIMB AND FELT A POP IN THE HIP. X-RAYS AT AN OUTSIDE EMERGENCY DEPARTMENT REVEALED A LEFT PERIPROSTHETIC FEMUR FRACTURE WITH CLEARLY SUBSIDENCE OF THE COMPONENT. REVISION NOTE REPORTED A SERIES OF CERCLAGE WIRES WERE UTILIZED TO STABILIZED THE REDUCTION AND EXCELLENT REDUCTION WAS ACHIEVED. DOI: (B)(6) 2016; DOR: (B)(6) 2016 (LEFT HIP).

  Patient problems: Bone Fracture(s); Discomfort; No Code Available; Pain

  MAUDE report 9899166 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUP, SCREW, LINER, AND HEAD WERE REVISED. THE CUP WAS VERTICAL. SCREW INFORMATION NOT AVAILABLE. DOI: (B)(6) 2010; DOR: (B)(6) 2019 (LEFT HIP).

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

  MAUDE report 9889834 ↗
• InjuryJan 30, 2020Adverse 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 LEFT HIP PAIN, THE PRODUCTS WERE REPLACED WITH PINNACLE/ALTRX/CERAMIC. THERE WAS NO VISIBLE SIGNS OF METALLOSIS. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Injury; No Code Available; Pain; Test Result

  MAUDE report 9647007 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, SUFFERING, INJURY, AND LOCAL TISSUE REACTION. PATIENT'S ORTHOPAEDIC SURGEON RECOMMENDED REVISION SURGERY. DOI: (B)(6) 2011; DOR (NOT REPORTED); LEFT HIP.

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

  MAUDE report 9309934 ↗
• InjuryNov 12, 2019Naturally Worn; Naturally Worn

  REASON FOR ORIGINAL COMPLAINT. -THE PATIENT WAS FIRST REVISED TO ADDRESS A FRACTURED LINER; THE SALES REP WAS NOT AWARE OF ANY PREVIOUS REVISIONS. THE PATIENT WAS THEN REVISED TO ADDRESS PAIN CAUSED BY CUP MALPOSITIONING AND THE SUBSEQUENT METAL WEAR. IT WAS STATED IN THE REPORTING THAT THE CUP WAS VERY VERTICAL. DOI: (B)(6) 2007. DOR: (B)(6) 2007. DOR: (B)(6) 2011. UPDATE - LITIGATION PAPERS RECEIVED. IN ADDITION TO PREVIOUSLY REPORTED ALLEGATIONS, IT IS NOW ALLEGED THAT UPON THE (B)(6) 2011 REVISION THAT THE PATIENT SUFFERS FROM SEVERE METALLOSIS AND SEVERE OSTEOLYSIS, ALONG WITH ASSOCIATED BONE DEFECTS. INITIAL EMDRS HAVE BEEN CREATED. UPDATE - 12/4/2012 - MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THE REVISION OPERATIVE REPORT OF (B)(6) 2007 INDICATED THE PATIENT WAS REVISED DUE TO DISASSOCIATION. ADDITIONALLY IT WAS NOTED THAT THE ACETABULAR CUP WAS PUT INTO MORE ANTEVERSION AT THE INITIAL PROCEDURE DUE TO STABILITY ISSUES. UPDATE OCT 16, 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES GRINDING SENSATION DIFFICULTY IN WALKING, ELEVATED CHROMIUM METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS

  Patient problems: Cyst(s); Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 9309507 ↗
• MalfunctionNov 7, 2019Fracture; Patient-Device Incompatibility; Device-Device Incompatibility; Fracture; Patient-Device Incompatibility; Device-Device Incompatibility

  SIZE 6 HI SUMMIT WAS IMPLANTED AND SAT UP. DR. (B)(6) ATTEMPTED TO REMOVE THE STEM TO REBROACH, BUT THE THREADED EXTRACTOR WOULD NOT THREAD INTO THE STEM. AFTER SEVERAL FAILED ATTEMPTS, WE HAD TO USE A VICE GRIP AND SLAP HAMMER TO REMOVE THE STEM. THE NECK OF THE IMPLANT WAS SLIGHTLY DAMAGED FROM THIS, SO WE HAD TO OPEN A NEW IMPLANT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 10. ACTION TAKEN WHEN EVENT OCCURRED? OPENED NEW IMPLANT AND EXTRACTED OLD ONE WITH VICE GRIP. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: -->NONE. (B)(4). DEVICE PROPERTY OF: HOSPITAL. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THRO

  Patient problems: Not Applicable

  MAUDE report 9292938 ↗
• InjuryAug 16, 2019Naturally Worn; Naturally Worn

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. PATIENT WAS REVISED TO ADDRESS HIGH CHROMIUM ION LEVEL. WAS FEELING SICK AND HAD HIP PAIN. DOI (B)(6) 2007 - DOR (B)(6) 2012 (RIGHT HIP) . **UPDATE: 8/22/13 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION AND DIFFICULTY AMBULATING. DURING THE REVISION SURGERY, IT WAS NOTED THAT PATIENT HAD GRAY STAINING MATERIAL CONSISTENT WITH METALLOSIS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY. DURING OPERATION, UPON REMOVAL OF THE FEMORAL HEAD, THERE WAS AN OBVIOUS METALLOSIS AND STAINING AROUND THE TRUNNION AND NECK CONSISTENT WITH A METAL-METAL WEAR. THIS WAS THEN COMPLETELY CLEANED. NO FURTHER UNUSUALITY NOTED. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (RIGHT HIP).

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

  MAUDE report 8903140 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION WITH SYNOVITIS. REVISION NOTES REPORTED THAT THE HIP CAPSULE WAS SCARRED AND WAS EXCISED. THE ACETABULUM WAS EXPOSED AND REMOVED ALL THE SYNOVITIS. THERE WAS SOME BLACK DEBRIS IN THE TRUNNION THEN WAS CLEANSED AND DRIED. CLINICAL VISITS REPORTED PAIN, SLIGHT ELEVATION IN METAL IONS WITH SIGNIFICANT INFLAMMATION IN THE ILIOPSOAS TENDON SHEATH. ADDITIONALLY, IT WAS NOTED THAT DURING THE INITIAL HIP REPLACEMENT, THE FEMUR FRACTURED DURING IMPLANTATION OF THE STEM; THE FRACTURE WAS THEN STABILIZED WITH A CABLE. DOI: (B)(6) 2008; DOR: (B)(6) 2018; (LEFT HIP).

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

  MAUDE report 8740719 ↗
• InjuryJun 14, 2019Loss of Osseointegration; Unintended Movement; Loss of Osseointegration; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAD LOOSENING OF THE FEMORAL STEM AT BONE TO IMPLANT INTERFACE, THE STEM ALSO SUBSIDED DUE TO FRACTURE IN THE PROXIMAL FEMUR AND WAS REMOVED. CABLES WERE PLACED AND A NEW REVISION STEM WAS PLACED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8699947 ↗
• InjuryMay 30, 2019Biocompatibility; Biocompatibility

  COBALT METAL ION LEVEL IS ABOVE 7PPB.

  Patient problems: No Code Available; Pain; Scar Tissue; Test Result; Tissue Damage

  MAUDE report 8653462 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN VERIFIED THAT THERE WAS NO INFECTION. PFS OPERATIVE NOTE INDICATED THAT THERE WERE NO ORGANISMS FROM CULTURES TAKEN AT REVISION.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8595189 ↗
• InjuryMay 8, 2019Biocompatibility; Biocompatibility

  LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED PAIN, SWELLING, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, PSEUDOTUMORS, BURSITIS, AND BONE EROSION. UPDATE THE PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN/DISCOMFORT. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: B)(6) 2013 (RIGHT HIP).

  Patient problems: Discomfort; Erosion; Inflammation; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Test Result; Tissue Damage

  MAUDE report 8590865 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP ARTHROPLASTY. REVISION NOTE STATED, THE PATIENT HAD OBVIOUS METAL STAINING THROUGHOUT THE TISSUES. THE STEM SHOWS A LITTLE BIT OF TRUNNIONOSIS.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8577712 ↗
• InjuryApr 23, 2019Biocompatibility; Biocompatibility

  PATIENT REVISED FOR INFECTION. UPDATE: LITIGATION PAPERS WERE RECEIVED. THEY ALLEGE THAT PATIENT SUFFERED FROM SEVERE PAIN AND DISCOMFORT. UPDATE: IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2010; (LEFT HIP) FIRST REVISION./

  Patient problems: Discomfort; No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 8541839 ↗