ASPHERE 1365-06-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295032991), received between Jun 29, 2017 and Apr 28, 2026 — classified as 29 injuries.

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 29 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASHOUT AND HEAD/LINER EXCHANGE DUE TO POSSIBLE INFECTION. ORIGINAL DATE OF SURGERY IS UNKNOWN BUT APPROXIMATELY 15 YEARS AGO WAS MENTIONED. NO MORE INFORMATION KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25020538 ↗
• InjuryMay 23, 2023Degraded; Naturally Worn; Degraded; Naturally Worn

  LITIGATION ALLEGES METAL POISONING FROM TOXIC HEAVY METALS AND REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE DEFECTIVE SYSTEM. PLAINTIFF SUFFERED INJURIES INCLUDING PAIN, INJURY, METALLOSIS, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE AND LIMITATION OF DAILY ACTIVITIES. DOI: ON (B)(6) 2012, DOR: ON (B)(6) 2022, SIDE: RIGHT HIP.

  Patient problems: Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Pain

  MAUDE report 16988705 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S PRIMARY HIP WAS REVISED DUE TO INSTABILITY. DURING THE REVISION PROCEDURE, THE PATIENT'S PRIMARY 40MM METAL FEMORAL HEAD AND PINNACLE ULTAMET METAL ACETABULAR LINER WERE REMOVED. THEY WERE REPLACE BY A 36MM +5 BIOLOX DELTA TS CERAMIC FEMORAL HEAD AND A PINNACLE POLYETHYLENE CONSTRAINED 36MM X 56MM +4 NEUTRAL ACETABULAR LINER. DOI: UNKNOWN. DOR: (B)(6)2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16983268 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FAILED METAL ON METAL ULTAMET BEARING. ELEVATED METAL ION LEVELS AND PAIN. REVISED TO POLY LINER AND REVISION CERAMIC HEAD. THERE WAS NO LOOSENING. THERE WAS A SURGICAL DELAY OF 1.5 HOURS. DOI: UNKNOWN. OR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15209333 ↗
• InjuryApr 11, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  REVISION COMPLETED DUE TO CONCERNS OF ELEVATED METAL ION POSSIBILITY. PATIENT REVISED TO A CERAMIC HEAD BALL. DOI: (B)(6) 2008. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14073549 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 25 FEB 2022. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO PAINFUL LEFT TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2011, DOR: (B)(6) 2013, LEFT HIP.

  Patient problems: Pain

  MAUDE report 13801683 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD FOR EM 3.15 AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO SEPTIC RIGHT TOTAL HIP HAD FAILED CONSERVATIVE TREATMENT INCLUDING LAVAGE WITH COMPONENT RETENTION, LOOSENING OF THE ACETABULAR COMPONENT. THE PLATE ITSELF HAD FRACTURED AND IT WAS GROSSLY LOOSE WITH PURULENT FIBROUS TISSUE, SOME DRAINAGE PRESENT AND HAD BEEN OVERGROWN BY HETEROTOPIC BONE. THE ACETABULUM ITSELF WAS ERODED WITH SEVERAL SMALL AREAS OF FULL-THICKNESS PENETRATION, NECROTIC DEBRIS WAS NOTED IN THE FLOOR OF THE ACETABULUM. DOI: (B)(6) 2010, DOR: (B)(6) 2010, RIGHT HIP.

  Patient problems: Adhesion(s); Extraskeletal ossification; Necrosis; Pocket Erosion; Unspecified Infection

  MAUDE report 13769889 ↗
• InjurySep 8, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

  PINNACLE MOM LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RESULTING IN INJURY, SWELLING HIP, PAIN, NECROTIC TISSUE, PSEUDOTUMOR, DAMAGE MUSCLE AND BONE. OPERATIVE NOTE REPORTED A LARGE 1-2 L OF FLUID, EXTENSIVE DESTRUCTION OF THE PERIARTICULAR SOFT TISSUES, HIP ABDUCTOR DESTRUCTION, MULTIPLE FLUIDS COLLECTION AND COPIOUS AMOUNT OF CHOCOLATE BROWN FLUID, METAL WEAR. PATIENT IS ALSO EXPERIENCING EMOTIONAL TRAUMA AND DISTRESS. PLAINTIFF IS SEEKING COMPENSATORY DAMAGES. DOI: (B)(6) 2010; DOR: (B)(6) 2020; HIP UNKNOWN.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Nerve Damage; Pain; Physical Asymmetry; Pocket Erosion; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 12443855 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS "REVISED MOM IMPLANT DUE TO ELEVATED ION LEVELS.". DOI: UNKNOWN DOR: (B)(6). 2021 AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11745065 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ELEVATED COBALT SERUM LEVELS OF 12.2 AND CHROMIUM SERUM LEVEL OF 2.5. THE PATIENT HAS BEEN MONITORED FOR THE ABOVE LEVELS. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11049892 ↗
• InjuryAug 19, 2020Degraded; Naturally Worn; Degraded; Naturally Worn

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR ABERRANT WEAR MECHANISM RIGHT THA. OPERATIVE NOTES REPORTED THAT THERE WAS A PSEUDOTUMOR AREA THAT HAD PROPAGATED POSTERIORLY THROUGH THE GLUTEUS. THERE WAS SOME TAPER CORROSION, ALTHOUGH THE THREADS ON THE TAPER STILL APPEARED INTACT. THERE WAS HAD A BROWNISH GREENISH DISCOLORATION. SURGEON NEEDED TO DEBRIDE THE DEVITALIZED AND DEAD TISSUE. DOI: (B)(6) 2010; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Necrosis; No Code Available

  MAUDE report 10427841 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BEEN DOING FINE WITH THE IMPLANTS UP UNTIL THE LAST 6 MONTHS OR SO, THEN PATIENT WAS HAVING INCREASED SORENESS IN THE HIP WHICH LED TO REVISION. AFFECTED SIDE: RIGHT HIP

  Patient problems: Discomfort; No Code Available

  MAUDE report 10167202 ↗
• InjuryApr 1, 2020Corroded; Naturally Worn; Corroded; Naturally Worn

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP REPLACEMENT DUE TO METALLOSIS, ARTICULAR SURFACE WEAR, AND CORROSION. IT WAS INDICATED THAT THE PATIENT HAS ELEVATED METAL LINES AND SIGNS OF CORROSION AND WEAR OF ARTICULAR SURFACE OF PREVIOUSLY PLACED METAL-ON-METAL HIP REPLACEMENT. OPERATIVE FINDINGS STATED FAILED LEFT TOTAL HIP REPLACEMENT METAL-ON-METAL CONSTRUCT DUE TO BOTH TRUNNIONOSIS AND METALLOSIS. THERE WAS NO SIGNIFICANT OSTEOLYSIS IN THE ACETABULAR SHELL AND FEMORAL STEM WAS WELL FIXATED WITH NO MECHANICAL COMPROMISE OF THE LOCKING MECHANISM OR TRUNNION. THIS WAS DESPITE SOME ELEMENT OF TRUNNIONOSIS AND SOME BACK SITE CORROSION AND METALLOSIS. THERE WAS NO PSEUDOTUMOR: THE PROCEDURE INCORPORATED SYNOVECTOMY OF THE JOINT, REMOVAL OF THE FEMORAL AND ACETABULAR BEARING SURFACE COMPONENT, AND REVISION OF BOTH THESE COMPONENTS. DOI: (B)(6) 2009 - DOR: (B)(6) 2019 (LEFT HIP).

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

  MAUDE report 9911114 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM ALLEGES PAIN, OSTEOLYSIS, METALLOSIS AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS METALOSIS LEFT HIP. REVISION NOTES REPORTED THAT THERE WAS EVIDENCE OF METALOSIS. THERE WAS LOBULAR SYNOVIUM WHICH WAS GRAY IN COLOR. DOI: (B)(6) 2010; DOR: (B)(6) 2018 (LEFT HIP). THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE RIGHT HIP.

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

  MAUDE report 9843241 ↗
• InjuryJan 21, 2020Corroded; Naturally Worn; Corroded; Naturally Worn

  THE PATIENT THEN WAS REVISED FOR PAINFUL RIGHT TOTAL HIP ARTHROPLASTY WITH METAL WEAR.

  Patient problems: Adhesion(s); Necrosis; No Code Available; Pain; Test Result

  MAUDE report 9613482 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2009. DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9545540 ↗
• InjuryMay 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD RECURRENT DISLOCATION DUE TO TISSUE CHANGES RESULTING FROM METALOSIS." NO ADDITIONAL INFORMATION. ORIGINAL CUP WAS IMPLANTED (B)(6) 2007. CHANGED TO METAL LINER (B)(6) 2009. DOI: (B)(6) 2007 (CUP), DOI: (B)(6) 2009 (LINER AND HEAD), DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Tissue Damage

  MAUDE report 8627237 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES PSEUDOTUMOR, BONE FRACTURE, DISLOCATION AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2011 - DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Joint Dislocation; Test Result; Tissue Damage

  MAUDE report 8603265 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR PAINFUL LEFT THA, LIKELY SECONDARY TO METAL DEBRIS FROM METAL-ONE METAL REPLACEMENT. THERE WAS SOME LARGE AMOUNT OF BONE ANTERIORLY, WHICH MAY REPRESENT SMALL OSTEOPHYTES OR SOME HETEROTROPIC CALCIFICATION. THE DEEP TISSUES OF THE HIP WERE NOT STAINED WITH METAL DEBRIS.

  Patient problems: Discomfort; Extraskeletal ossification; Joint Disorder; No Code Available; Pain; Test Result

  MAUDE report 8469153 ↗
• InjuryMar 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2011; DOR: (B)(6) 2014; (LEFT HIP) SECOND REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8395238 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL GROIN AREA AND HIP. SURGEONS ORIGINAL PLAN WAS TO REMOVE MOM LINER/ METAL HEAD AND CONVERT TO CERAMIC ON POLY CONSTRUCT. THE AML STEM PRESENTED TO BE LOOSE PROXIMALLY. SURGEON ELECTED TO REMOVE THE STEM AND STEM BROKE AT MID SHAFT LEAVING THE DISTAL 1/2 STILL FIXED IN THE CANAL. AN OSTEOTOMY WAS MADE AND USING A TREPHINE THE DISTAL PORTION WAS CAPTURED. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2012. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 8374365 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP PAIN FOLLOWING 2ND HIP REVISION FROM AN ASR IN 2009.

  Patient problems: No Code Available; Pain

  MAUDE report 8285890 ↗
• InjuryJan 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH OPEN REDUCTION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8256851 ↗
• InjuryDec 20, 2018Corroded; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Corroded; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

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

  MAUDE report 8184464 ↗
• InjuryJun 15, 2018Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE PATIENT HAD A METAL ON METAL TOTAL HIP IMPLANTED BY THE SURGEON IN 2009. SURGEON REVISED THE METAL ON METAL COMPONENTS DUE TO PAIN FROM THE METAL BEARING. THERE WERE NO SIGNS OF INFECTION PRESENT. THE PATIENT DID HAVE TISSUE AROUND THE JOINT THAT WAS CONSISTENT OF METALLOSIS REACTION. SURGEON REPLACED THE EXPLANTED PARTS WITH A 56X36 +4/10* LINER AND A 36+5 CERAMIC HEAD. SURGEON WAS ADVISED THAT IT WOULD BE OFF LABEL TO US A CERAMIC HEAD WITHOUT A REVISION SLEEVE. HE ACKNOWLEDGED AND WANTED TO PROCEED WITH A PRIMARY CERAMIC HEAD. DOI: (B)(6) 2009; DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Fall; Foreign Body Reaction; No Code Available; Pain; Synovitis; Tissue Damage

  MAUDE report 7604772 ↗