ASPHERE 1365-05-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295032977), received between Mar 7, 2013 and Aug 12, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50225717 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO METAL ION LEVELS AND THE FROM METAL-ON-METAL WAS CONVERTED TO DUAL MOBILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 17297555 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD METALLOSIS CAUSED BY A METAL LINER AND CUP WAS VERTICAL SO SURGEON REMOVED CUP AND REPLACED WITH COMPETITIVE CUP AND CERAMIC ON POLY CONSTRUCT ON OUR SUMMIT STEM. DOI: (B)(6) 2011 - DOR: DOR: (B)(6) 2021 (LEFT HIP)

  Patient problems: Foreign Body Reaction

  MAUDE report 12088392 ↗
• InjuryApr 29, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED AS "REVISED A PINNACLE METAL ON METAL TO A NEW CUP, POLY LINER AND A CERAMIC TS HEAD. ORIGINAL CUP WAS MALPOSITIONED. A LOT OF METALLOSIS IN THE JOINT. HIGH COBALT/ CHROMIUM LEVELS". DOI: (B)(6) 2009. DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Extraskeletal ossification; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11743897 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AD 15 JAN 2021: UNFILED CLAIM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAINFUL, SYMPTOMATIC MODULAR METAL ON METAL POSTERIOR TOTAL HIP ON THE LEFT SIDE. OPERATIVE NOTE REPORTED OF METALLOSIS AND OSTEOLYTIC LESION BEHIND THE SOCKET. THE PATIENT COMPLAINED THAT THE LEG HAD BEEN A LITTLE BIT SHORT. DOI: (B)(6) 2010, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Foreign Body Reaction; Pain; Physical Asymmetry

  MAUDE report 11310995 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL HIP. SURGEON EXPLANTED METAL LINER AND HEAD TO CERAMIC/POLY. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 10896905 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED METAL ON METAL LEFT TOTAL HIP REPLACEMENT WITH ELEVATED COBALT, SYNOVITIS/FIBROSIS. OPERATIVE NOTES INDICATED PAIN, OSTEOLYSIS AND PSEUDOTUMOR. DOI: (B)(6) 2010 DOR: (B)(6) 2018 LEFT HIP. PLEASE SEE (B)(4) FOR RIGHT HIP.

  Patient problems: Fibrosis; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Pain; Synovitis; Test Result

  MAUDE report 10580876 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT ALLEGES PAIN AND ELEVATED COBALT. DOI: (B)(6) 2011. DOR: NONE REPORTED RIGHT HIP

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 10580793 ↗
• InjuryMar 19, 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 METALLOSIS OF THE RIGHT HIP. THE 40MM HEAD WAS REPLACED WITH CERAMIC HEAD. DOI: (B)(6) 2009, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9855841 ↗
• InjuryMar 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, PATIENT WAS REVISED TO ADDRESS METALLOSIS AND METAL IONS. PATIENT HAS FAILED RIGHT TOTAL ARTHROPLASTY WITH METAL ION OSTEOLYSIS. REVISION NOTES REPORTED THAT THERE WAS SIGNIFICANT METALLOSIS IN THE SOFT TISSUES. THE CUP ANTEVERSION WAS INADEQUATE AND THE CUP WAS REMOVED WITHOUT IATROGENIC BONE LOSS. DOI: (B)(6) 2010; DOR: (B)(6) 2018; RIGHT HIP.

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

  MAUDE report 9831516 ↗
• InjuryFeb 18, 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 COMPLAINED OF PAIN AND DISABILITY. THEN WAS REVISED FOR MECHANICAL PROBLEMS RIGHT HIP PROSTHESIS. IT WAS INDICATED THAT THE COBALT/CHROMIUM SERUM LEVELS REVEALED SIGNIFICANT ELEVATION OF THE COBALT LEVEL CONSISTENT WITH TRUNNIONOSIS. IMAGING REVEALED WELL FIXED IMPLANTS BUT EVIDENCE OF MILD PERIPHERAL OSTEOLYSIS IN THE SUPERIOR LATERAL ACETABULUM. THE PATIENT IS UNDERGOING HIP REVISION SURGERY TO TREAT THE PAIN AND METALOSIS. OPERATIVE NOTES REPORTED THAT INSPECTION OF THE TRUNNION REVEALED SIGNIFICANT METALOSIS AND CORROSION. 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 9720712 ↗
• InjuryFeb 18, 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 COMPLAINED OF PAIN AND DISABILITY. THEN WAS REVISED FOR MECHANICAL PROBLEMS RIGHT HIP PROSTHESIS. IT WAS INDICATED THAT THE COBALT/CHROMIUM SERUM LEVELS REVEALED SIGNIFICANT ELEVATION OF THE COBALT LEVEL CONSISTENT WITH TRUNIONOSIS. IMAGING REVEALED WELL FIXED IMPLANTS BUT EVIDENCE OF MILD PERIPHERAL OSTEOLYSIS IN THE SUPERIOR LATERAL ACETABULUM. OPERATIVE NOTES REPORTED THAT THE FEMORAL COMPONENT WAS INSPECTED AND NOTED TO HAVE CORROSION AND METALOSIS AROUND THE TRUNION. NO LABS PROVIDED FOR THE ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2009; DOR: (B)(6) 2018; RIGHT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE LEFT HIP

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

  MAUDE report 9720653 ↗
• InjuryJan 17, 2020Corroded; Naturally Worn; Corroded; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD METAL ON METAL WEAR AND COMPLAINED OF HIP PAIN. ONCE THE METAL HEAD AN LINER WERE REMOVED, THERE WAS NOTICEABLE CORROSION ON THE PROXIMAL ASPECT OF THE STEM AND HEAD. THE SURGEON REPLACED THE HEAD AND LINER. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9603854 ↗
• InjuryNov 18, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP, BONE FRACTURE, INFECTION, LOOSENING OF STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2012 (LEFT HIP). AT THIS TIME IT¿S UNKNOWN WHERE THE FRACTURE OCCURRED. IF/WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED. PATIENT IS BILATERAL. PLEASE SEE (B)(4) FOR THE RIGHT HIP. THIS PC IS FOR THE FIRST REVISION OF THE LEFT HIP. SEE (B)(4) FOR THE SECOND REVISION.

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

  MAUDE report 9337421 ↗
• InjuryNov 18, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP, BONE FRACTURE, INFECTION, LOOSENING OF STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS.

  Patient problems: Foreign Body Reaction; Test Result; Unspecified Infection

  MAUDE report 9336793 ↗
• InjuryOct 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE RECURRENT DISLOCATION. OPERATIVE NOTES REPORTED, THERE WAS SOME METALLOSIS AS WELL AS SIGNIFICANT FLUID ANTERIOR. THERE DID NOT APPEAR TO BE ANY OBVIOUS IMPINGEMENT WHICH CAUSES DISLOCATION HOWEVER WITH THE CAPSULE BEING TORN THERE WAS EXTRA SPACE ANTERIORLY WHICH ALLOWED FOR THE HIP TO SUBLUX ANTERIORLY. DOI: (B)(6) 2012 - DOR: (B)(6) 2012 (LEFT HIP, SECOND REVISION) PLEASE SEE (B)(6), FOR THE FIRST REVISION.

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

  MAUDE report 9207717 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS METALOSIS. DOI: (B)(6) 2011, DOR: (B)(6) 2019, RIGHT HIP.

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

  MAUDE report 8636028 ↗
• InjuryApr 8, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES LOOSENING OF CUP, BONE FRACTURE, INFECTION, LOOSENING OF STEM, METAL WEAR METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Adhesion(s); Discomfort; Distress; Metal Related Pathology; Osteolysis; Pain; Test Result; Tissue Damage; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8491373 ↗
• InjuryFeb 26, 2019Adverse 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) 2011. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8369814 ↗
• InjuryJan 16, 2019Material Disintegration; Material Disintegration

  LITIGATION ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8252343 ↗
• InjuryDec 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN, METALLOSIS AND TORN ABDUCTION.

  Patient problems: Pain; Tissue Damage

  MAUDE report 8163996 ↗
• InjuryOct 22, 2018Material Disintegration; Naturally Worn; Material Disintegration; Naturally Worn

  PPF ALLEGES METALLOSIS AND PSEUDOTUMOR. ADDED EXPIRATION DATE AND DOB. UPDATED STEM DETAILS. ADDED 2 SCREWS TO THE COMPLAINT.

  Patient problems: Deformity/ Disfigurement; Discomfort; Host-Tissue Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain; Test Result

  MAUDE report 7991473 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES PAIN.

  Patient problems: Discomfort; Inflammation; Injury; Pain; Test Result; Tissue Damage

  MAUDE report 7974847 ↗
• InjuryOct 17, 2018Material Disintegration; Insufficient Device Problem Information; Material Disintegration; Insufficient Device Problem Information

  LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PLAINTIFFS BLOOD. AS A RESULT HE BEGAN EXPERIENCING INJURY, INFLAMMATION, PAIN, DISCOMFORT, INCLUDING WHEN AMBULATING OR MOVING TO AND FROM A SITTING POSITION. PLAINTIFF HAS NOT HAD THE RIGHT HIP IMPLANT EXPLANTED YET, BUT HAS A RECOMMENDATION FOR REVISION AND PLANT TO HAVE A REVISION SURGERY IN THE NEAR FUTURE.

  Patient problems: Discomfort; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 7974559 ↗
• InjurySep 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7859517 ↗