ASPHERE 1365-51-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295033929), received between Aug 19, 2014 and Sep 30, 2024 — classified as 35 injuries.

The most frequently reported specific device problem is “Naturally Worn” (18 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 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. ON (B)(6) 2023, PATIENT UNDERWENT A REVISION DUE TO PAIN AND LOSS OF FUNCTION SECONDARY TO METALLOSIS.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Pain

  MAUDE report 20335761 ↗
• InjuryJul 26, 2023Naturally Worn; Naturally Worn

  PINNACLE MEDICAL RECORDS RECEIVED. PATIENT REPORTED METAL ON METAL RIGHT HIP WITH HIGHLY ELEVATED CHROMIUM AND NICKEL SERUM LEVELS, RETRO METALLOSIS, RETRO ACETABULAR OSTEOLYSIS, IMPINGEMENT AND CUP MALPOSITION. PATIENT IS ALLERGY TO LATEX.. DOI: (B)(6) 2011; DOE:(B)(6) 2020, RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 17396642 ↗
• InjurySep 23, 2022Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  SURGEON STATED THAT PATIENT WAS PRESENTED TO CLINIC WITH PAIN. REMOVED PINNACLE METAL ON METAL LINER, AS WELL AS TWO SCREWS AND COCR FEMORAL HEAD AND REPLACED WITH POLY LINER AND CERAMIC HEAD WITH TS SLEEVE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Synovitis

  MAUDE report 15469747 ↗
• InjuryJun 30, 2022Naturally Worn; Naturally Worn

  MOM PINNACLE LITIGATION RECORD RECEIVED. PATIENT ALLEGES ELEVATED METAL ION, SUFFERED INJURY TO HIS MUSCLE AND TISSUE, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY, SUFFERED INJURIES, PAIN, METALLOSIS, METAL WEAR, LOSS OF ENJOYMENT OF LIFE, LIMITATION OF DAILY ACTIVITIES, PHYSICAL DISABILITY, EXPERIENCED EMOTIONAL TRAUMA AND DISTRESS, MENTAL ANGUISH, AND ECONOMIC LOSS, PERMANENT INSTABILITY AND LOSS OF BALANCE, IMMOBILITY, AND SUFFERING, DOI: (B)(6) 2010, DOR: (B)(6) 2021, (UNKNOWN HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Blurred Vision; Discomfort; Distress; Dizziness; Ecchymosis; Fatigue; Foreign Body Reaction; Headache; Hearing Impairment; Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Necrosis; Numbness; Pain; Rash; Swelling/ Edema; Synovitis; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 14874666 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. I&D WITH HEAD AND LINER WAS EXCHANGED. THERE WAS NO LOOSENING. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14564420 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL HIP. METAL ON METAL HIP REVISED TO CERAMIC ON POLYETHYLENE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14079621 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT THE SURGEON STATES PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY 10-11 YEARS AGO. CORAIL STEM, 36 +1.5 METAL HEAD, 50 METAL ON METAL LINER AND A 50 PINNACLE CUP. PHYSICIAN STATES THE PT HAS LEFT HIP PAIN. PTS MOM LINER WAS REMOVED AS WELL AS THE HEAD. STEM WAS NOT LOOSE. THE CUP WAS NOT LOOSE. THE LINER WAS REPLACED WITH A POLY LINER AND CERAMIC TS HEAD. THE PART # FOR THE 36 METAL HEAD IS NOT KNOWN BY THE REP. THE LOT # IS STATED. HEAD IS 36+1.5. DOI: 10-11 YEARS AGO. DOR: (B)(6) 2021. AFFECTED SIDE LEFT HIP.

  Patient problems: Pain

  MAUDE report 12454498 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: THE PATIENT WAS REVISED TO ADDRESS HIP PAIN, THE SURGEON REMOVED THE LINER AND HEAD AND IMPLANTED A REPLACEMENT LINER AND HEAD. THERE WERE NO SIGNS OF LOOSENING OF ANY COMPONENTS. DOI: UNK, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 12438368 ↗
• InjuryApr 5, 2021Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  AFTER A REVIEW OF THE OPERATIVE NOTES AND STICKER SHEETS, THE PATIENT REPORTED HAVING PAIN BEGINNING SEVERAL YEARS EARLIER AND IT SIMPLY CONTINUED TO WORSEN. THE PATIENT CURRENTLY RATES HIS PAIN AS 5/10. PAIN IS IMPROVED WITH REST. THE PATIENT ALSO NOTED SOME SQUEAKING IN THE HIP THAT IS AUDIBLE TO HIM AND OTHERS.

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

  MAUDE report 11613799 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION OF METAL ON METAL LINER TO POLY ON CERAMIC DUE TO PAIN. DOI: 2010. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10771404 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REPORT ALVAL, HYPERSENSITIVITY, PSEUDOTUMOR, PAIN, TENDINOSIS, BURSITIS, ELEVATED METAL ION LEVELS, METALLOSIS AND FLUID COLLECTION. THE PATIENT WAS THEN REVISED TO ADDRESS PAIN, PSEUDOTUMOR AND METAL ON METAL REACTION. A SIGNIFICANT AMOUNT OF SYNOVIAL FLUID WAS ENCOUNTERED WITHIN THE JOINT ALONG WITH MILD OR MINIMAL AMOUNTS OF TRUNNIONS AND METALLOSIS TYPE MATERIAL OR TISSUE. DOI: (B)(6) 2010, DOR: (B)(6) 2019, (RIGHT HIP).

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

  MAUDE report 9897964 ↗
• InjuryJan 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION, SO WE REPLACED LINER TO A CONSTRAINED LINER. DOI: (B)(6) 2012; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9629264 ↗
• InjuryDec 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS ULTAMET LINER EXCHANGE TO A CONSTRAINED LINER. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9521096 ↗
• InjuryOct 3, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA REVISION DONE ON (B)(6) 2000 FOR A FEMORAL STEM THAT SUBSIDED. THAT SURGEON BACK THEN PUT IN AN AML 8 INCH STEM. SINCE THAT REVISION SURGERY THE PATIENT HAS NOW RECENTLY STARTED TO COMPLAINED ABOUT PAIN. THE NEW ORTHO SURGEON WANTED TO DO A HEAD AND LINER EXCHANGE BECAUSE THE THA PUT BACK IN 2000 WAS PINNACLE METAL ON METAL. THE SURGEON DID NOT SAY IF THE PATIENT HAD ELEVATED LEVELS, ETC. THE SURGEON REMOVED THE METAL LINER AND HEAD. HE SHOWED SOME METAL DEBRIS INSIDE THE METAL HEAD AND AROUND THE METAL LINER. THE SURGEON PUT IN A NEW POLY 36X52 NEUTRAL LINER AND 36 +12 TS CERAMIC HEAD. HE FELT THAT THE PATIENT WAS SHORT AND NEEDED TO BE LENGTHENED. HE PUT THE HIP THRU ROM AND WAS HAPPY WITH THE FINAL PRODUCT. DOI: (B)(6) 2000; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9150953 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION PRESENT. REMOVED METAL LINER AND METAL HEAD. NO OTHER DETAILS PROVIDED. DOI: (B)(6) 2011; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9071139 ↗
• InjuryApr 12, 2019Naturally Worn; Naturally Worn

  LITIGATION ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2013, LEFT HIP.

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

  MAUDE report 8508736 ↗
• InjuryApr 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES CLOSED DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2010; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8482358 ↗
• InjuryMar 28, 2019Biocompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER A REVIEW OF MEDICAL RECORDS, REVISION NOTES WERE REPORTED OF SEROUS FLUID. THE LINER, HEAD, AND STEM WERE REMOVED FROM THE CANAL WITH MINIMAL BONE ATTACHMENT. CLINIC VISITS REPORTED OF LARGE PSEUDOTUMOR, SWELLING, AND PAINFUL RIGHT LATERAL CONDYLE ABOVE THE HEAD OF THE FIBULA. PSUEDUTOMORS CONTAIN METAL IONS, OSTEOCYTES, WBCS, FLUID, AND OSTEOLYSIS. BONE SCAN REPORTED OF PERIPROSTHETIC FRACTURE. CORTICAL FRACTURE EMANATING FROM THE TIP OF THE PROSTHESIS. METAL DEBRIS GENERATED FROM TAPER JUNCTIONS APPEARS TO BE OF A DIFFERENT MORPHOLOGY. IT WAS ALSO REPORTED THAT THE IMPLANT WAS LIKELY ALREADY CORRODED WHEN IT WAS INSERTED. THERE WAS ALSO CONSISTENT OF INFLAMMATION AND SYSTEMIC COBALT TOXICITY FROM TOTAL HIP ARTHROPLASTIES. UPDATED EVENT DESCRIPTION: ON (B)(6) 2010 DURING THE CLINIC VISIT, A LARGE PSEUDOTUMOR BEGAN SWELLING, VERY HARD AND PAINFUL, ON THE RIGHT LATERAL CONDYLE ABOVE THE HEAD OF THE FIBULA, ABOUT THE SIZE OF A GOLF BALL. PSEUDOTUMORS CONTAIN METAL IONS, OSTEOCYTES, WBCS, AND FLUID. ON (B)(6) 2010, THE PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT TO ADDRESS DEGENERATIVE ARTHRITIS. IT WAS NOTED THAT AN AML PROSTHESIS WAS IMPLANTED IN THE FE

  Patient problems: Cramp(s) /Muscle Spasm(s); Depression; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Metal Related Pathology; Muscle Spasm(s); No Code Available; Pain; Swelling/ Edema; Test Result; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 8459457 ↗
• InjuryMar 11, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR, METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2015 (LEFT HIP). PATIENT IS BILATERAL.

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

  MAUDE report 8407806 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPRESSED PAIN AND DISCOMFORT. SURGEON SAID ION LEVELS WERE HIGH. REPLACED WITH POLY AND CERAMIC HEAD. DOI: (B)(6) 2009. DOR: (B)(6) 2019; LEFT HIP.

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

  MAUDE report 8386526 ↗
• InjuryFeb 5, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8304500 ↗
• InjuryJan 23, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METAL WEAR AND METALLOSIS.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8270256 ↗
• InjuryJan 22, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METALLOSIS AND METAL WEAR.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8267604 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGED ELEVATED METAL IONS AFTER THE FIRST REVISION. THE METAL HEAD AND STEM WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATION.

  Patient problems: Test Result

  MAUDE report 8236115 ↗
• InjuryJan 2, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS SUFFERED EXTREME PAIN IN THE HIP, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, PATIENT HAS EXPERIENCED THE EFFECTS OF METAL ION DEBRIS IN THE BODY, AND THE NEED FOR A REVISION SURGERY. DOI: (B)(6) 2010 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Pain; Test Result

  MAUDE report 8207783 ↗