ASPHERE 1365-52-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295033943), received between Jan 19, 2015 and Apr 27, 2026 — classified as 38 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY DUE TO EHLERS-DANLOS SYNDROME, DYSPLASTIC AND DEGENERATIVE RIGHT HIP. ON (B)(6) 2025, PATIENT UNDERWENT A REVISION, RIGHT TOTAL HIP ARTHROPLASTY DUE TO PAIN, METAL ON METAL WEAR WITH ELEVATED METAL ION LEVELS PRIOR SPINAL FUSION. DOI: (B)(6) 2010, DOR: (B)(6) 2025, AFFECTED SITE: RIGHT HIP. THE RELATED (B)(4) CAPTURES REVISION OF THE LEFT HIP DUE TO ELEVATED IONS AND PERSISTENT PAIN.

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

  MAUDE report 25006700 ↗
• InjuryNov 30, 2022Naturally Worn; Naturally Worn

  PINNACLE LITIGATION RECORDS RECEIVED. PATIENT IS SCHEDULED TO UNDERGO A REVISION SURGERY ON (B)(6) 2022 DUE TO HEAVY METAL POISONING. RECORDS ALSO ALLEGES PAIN, INJURY, SCAR TISSUE FORMATION, METALLOSIS, METAL WEAR AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6) 2011, DOR: (B)(6) 2022, RIGHT HIP, PLEASE SEE (B)(4) FOR LEFT HIP

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15891027 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED TO HOSPITAL FOR INFLAMMATORY. SURGERY WAS PERFORMED TO REMOVE METAL ON METAL IMPLANTS, LINER AND HEAD ONLY WAS REMOVED. TRUNIONOSIS.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 15586947 ↗
• InjuryAug 30, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION OF THE STEM AND LINER OF THE LEFT HIP. PATIENT HAD PINNACLE MOM LINER AND A CORAIL HIP STEM. PATIENT WAS EXPERIENCING PAIN AND ON X-RAY SHOWED METALLOSIS AROUND THE STEM. SURGEON SAID THAT HE DID NOT SEE ANY DAMAGE TO THE SOFT TISSUES BUT THERE WAS A LOT OF BONE LOSS AROUND THE STEM AND IT WAS GROSSLY LOOSE. FEMORAL STEM WAS LOOSE AT A NON-CEMENTED INTERFACE. THE CORAIL STEM CAME OUT WITH THE SURGEON'S FINGERS. THERE WERE NOTICEABLE MARKINGS ON BOTH THE METAL LINER AND TRUNNION. SURGEON THOUGHT THE CUP WAS IN GOOD POSITION AND WELL FIXED SO HE DECIDED TO LEAVE IN PLACE. REMOVED BOTH THE METAL LINER, STEM AND HEAD AND REPLACED THEM WITH A POLY LINER, RECLAIM STEM AND CERAMIC HEAD. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15321510 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIGH IONS IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2011. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 13789892 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNFILED CLAIM AND PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN AND FAILURE OF MECHANICAL RIGHT TOTAL HIP ARTHROPLASTY. OPERATIVE FINDINGS SUGGESTION OF TROCHANTERIC BURSITIS WITHOUT PRESENCE OF PSEUDOTUMOR. OPERATIVE NOTE REPORTED SOME ATTENUATION IN THE FASCIA RIGHT TROCHANTER. PREVIOUS ABDUCTOR REPAIR NOT COMPLETELY HEALED, THERE WAS NEW EROSION AND LARGE AMOUNT OF FLUID. PATHOLOGY REPORT EVIDENCE OF TROCHANTERIC BURSITIS. DOI: (B)(6) 2011; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Impaired Healing; Inflammation; Pain; Pocket Erosion; Swelling/ Edema

  MAUDE report 12916550 ↗
• InjuryDec 2, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

  UNFILED CLAIM AND PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO METAL WEAR AND CORROSION AND PAIN. OPERATIVE NOTE REPORTED TAPER JUNCTION CORROSION AT THE STEM. THERE WAS JOINT FLUID VISIBLE AS BURSAL FLUID, SLIGHTLY GRAY COLOR SUGGESTIVE OF METAL STAINING, CORROSION BOTH IN NECK AND THE TAPER OF THE HEAD. HOWEVER THERE WAS NO GROSS WEAR OF THE ARTICULATING SURFACE. PATHOLOGY REPORT MINOR CORROSION TO NECK OF FEMORAL COMPONENT, PROTEINACEOUS MATERIAL BETWEEN CUP AND LINER, BURSA OVER THE GREATER TROCH. DOI: (B)(6) 2011; DOR: (B)(6) 2019 ; LEFT HIP.

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 12916128 ↗
• InjuryNov 23, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  MEDICAL RECORDS RECEIVED. REVISION NOTES STATED THAT THERE WAS GRAYISH YELLOW-COLORED FLUID AND NOTED A BLACK COLOR AT THE TRUNNION AND HAD IMPINGEMENT OF THE NECK TO THE COMPONENT.

  Patient problems: Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12861375 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED JOINT. REMOVAL OF METAL LINER AND HEAD. REPLACED WITH CERAMIC ANG POLY. DOI: (B)(6) 2011, DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 12433923 ↗
• InjuryJan 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS. DOI: (B)(6) 2013, DOR: (B)(6), 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11223963 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING INCREASING GROIN PAIN. COMPONENTS ORIGINALLY IMPLANTED SOMETIME IN 2010 IN (B)(6). NO RECORDS AVAILABLE. DOI: 2010; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Pain

  MAUDE report 10391187 ↗
• InjuryApr 9, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED WORN METAL ON METAL ACETABULAR COMPONENT WITH METALLOSIS. REVISION NOTES STATED THAT BURSA AND METAL DEBRIS WERE REMOVED. HEAD, LINER, AND CUP WERE REMOVED. PATIENT EXPERIENCED DISLOCATION, PAIN, AND HAVE ELEVATED METAL ION LEVEL. DOI: (B)(6) 2010; DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Joint Dislocation; No Code Available; Pain

  MAUDE report 9944362 ↗
• InjuryMar 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS RIGHT HIP RECURRENT DISLOCATION. REVISION NOTES STATED THAT HEAD, LINER AND 1 FIXATION SCREW WAS REMOVED. DOI: (B)(6) 2009; DOR: (B)(6) 2016 (RIGHT HIP); DOI: (B)(6) 2007(SCREW).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9836980 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES DISCOMFORT, PAIN, WEAKNESS, WALKING DIFFICULTY, OSTEOLYSIS, METALLOSIS, ELEVATED METAL IONS, PSEUDOTUMOR, LOOSENING OF CUP AND STEM, LEG LENGTH DISCREPANCY( 1/2 INCH SHORTER THAN THE RIGHT LEG), BONE LOSS, LIMITED MOBILITY, MUSCLE AND LIGAMENT INJURY. THE PLAINTIFF IS SEEKING COMPENSATORY DAMAGES. DOI: (B)(6) 2010; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Discomfort; Edema; Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Test Result; Tissue Damage; Weakness

  MAUDE report 9818025 ↗
• InjuryMar 5, 2020Noise, Audible; Noise, Audible

  DER STATES THAT THE ULTAMET 36X52 METAL LINER AND 36+5 COCR HEAD REVISED TO CERAMIC ON POLY CONSTRUCT. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

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

  MAUDE report 9793081 ↗
• InjuryMar 4, 2020Adverse 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 PAIN, PSEUDOTUMOR AND METALLOSIS. INTRAOPERATIVE FINDINGS INCLUDE A SIGNIFICANT AMOUNT OF SCAR TISSUE, A LARGE FLUID-FILLED ENCAPSULATED SAC, MAJORITY OF THE EXTERNAL ROTATORS DESTROYED, SIGNIFICANT METALLOSIS/TRUNNIONOSIS WITH BLACK DEPOSITS ALONG THE TRUNNION OF THE FEMORAL NECK, BONE FRAGMENTATION DURING THE EXTENDED TROCHANTERIC OSTEOTOMY AND MILD METALLIC DEBRIS FROM THE BACKSIDE OF THE METALLIC LINER ON THE SHELL. DOI: (B)(6) 2011; DOR: (B)(6) 2019; (LEFT HIP).

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

  MAUDE report 9786510 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR RIGHT HIP SEROMA PROSTHETIC INFECTION WITH PAIN AND SWELLING. OPERATIVE NOTES REPORTED THERE WAS SOME DEGREE OF SOFT TISSUE LAXITY. ONLY THE FEMORAL HEAD WAS REVISED. DOI: (B)(6) 2010; DOR: (B)(6) 2010; RIGHT HIP. 2ND REVISION CAPTURE ON (B)(4).

  Patient problems: Edema; No Code Available; Pain; Seroma; Unspecified Infection

  MAUDE report 9581793 ↗
• InjuryJul 19, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES ELEVATED METAL IONS, METALLOSIS AND METAL WEAR. DOI: (B)(6) 2009 - DOR: (B)(6) 2017 (RIGHT HIP). PATIENT IS BILATERAL. PLEASE SEE PC-(B)(4) FOR THE LEFT HIP.

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

  MAUDE report 8808688 ↗
• MalfunctionJun 19, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2010, DOR: NONE REPORTED, (LEFT HIP). PATIENT IS BILATERAL. PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 8711966 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS SURGICAL SITE INFECTION. OPERATIVE NOTE REPORTED A SMALL VOLUME OF SEROPURULENT FLUID AND NOTED TO EGRESS FROM BENEATH THE GLUTEUS MAXIMUS. DOI: (B)(6) 2010; DOR: (B)(6) 2010; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8687266 ↗
• InjuryApr 5, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN, METALLOSIS, TENDONITIS AND WALKING DIFFICULTY. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND METALLOSIS. REVISION NOTES REPORTED A METALLOSIS-INDUCED INFLAMED JOINT FLUID AND SCAR TISSUES IN THE PSEUDOCAPSULE AREA. THE ASPIRATED FLUID FROM THE HIP WAS NEGATIVE FOR INFECTION AND THE APPEARANCE WAS MORE CONSISTENT WITH METAL REACTIVITY. METAL ION LEVELS WERE BELOW 7PPB. DOI: (B)(6) 2010 - DOR: (B)(6) 2011, (RIGHT HIP). UPDATE REC'D 10/15/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE.

  Patient problems: Discomfort; Foreign Body Reaction; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Scar Tissue; Tissue Damage

  MAUDE report 8486349 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2011 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8478079 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL THA AND SEROMA. REVISION NOTES REPORTED OF LARGE VOLUME OF BROWNISH-TINGED FLUID AND GRANULATION TISSUE. THERE WAS SOME EROSION OF CALCAR OF BONE STOCK. THE STEM AND CUP WERE INTACT. THERE WAS ALSO AN EXTENSION OF PSEUDOTUMOR SEROMA. DOI: (B)(6) 2011, DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: Erosion; No Code Available; Pain; Seroma; Tissue Damage

  MAUDE report 8460013 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGED ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2012; DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Test Result

  MAUDE report 8387557 ↗
• InjuryMar 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES DISLOCATION, INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2011 - DOR: (B)(6) 2013, (LEFT HIP).

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

  MAUDE report 8381716 ↗