ASPHERERecalls & reported problems across all models

We found 19 models of ASPHERE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 223 adverse event reports in the FDA's MAUDE database, received between Feb 13, 2013 and Aug 27, 2026 — classified as 220 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (63 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ASPHERE problems

ASPHERE models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ASPHERE 1365-52-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  39 reports
• ASPHERE 1365-51-100

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  35 reports
• ASPHERE 1365-05-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  29 reports
• ASPHERE 1365-06-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  29 reports
• ASPHERE 1365-53-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  18 reports
• ASPHERE 1365-07-100

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  13 reports
• ASPHERE 1365-50-100

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  13 reports
• ASPHERE 1365-04-100

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  10 reports
• ASPHERE 1365-31-100

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  10 reports
• ASPHERE 1365-33-100

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  6 reports
• ASPHERE 1365-26-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  4 reports
• ASPHERE 1365-32-100

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  4 reports
• ASPHERE 1365-54-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  4 reports
• ASPHERE 1365-42-600

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  2 reports
• ASPHERE 1365-43-600

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  2 reports
• ASPHERE 1365-55-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  2 reports
• ASPHERE 1365-34-100

  Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
  1 report
• ASPHERE 1365-36-100

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report
• ASPHERE 1365-44-600

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report

Recent ASPHERE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

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

  It was reported on (b)(6) 2010, patient received a primary left total hip replacement to address avascular necrosis of the left femoral head, and degenerative joint disease of the left hip. Implants placed were DePuy 52 mm diameter Pinnacle 100 acetabular cup with an apex hole eliminator, 36 mm inner diameter by 52 mm outer diameter neutral Pinnacle metal acetabular insert, and a 36 mm +6 aSPHERE metal-on-metal femoral head, an S-ROM 18 x 13 femoral stem with 36 + 8 lateral off set neck, 18D small ZTT sleeve. There were no complications reported.(b)(6) 2023, the patient allegedly developed sudden onset of severe left hip and groin pain accompanied by a pulling sensation. Although some medical records reference a possible slip and fall, the patient does not recall any fall and reports that the symptoms began spontaneously. Due to worsening pain, the patient sought medical evaluation in (b)(6) 2023. Diagnostic imaging reportedly revealed osteolysis, a left lesser trochanter fracture, and significant osteolytic disease involving the proximal femur associated with a large-head Metal-on-Metal hip articulation. Subsequent Metal-on-Metal testing and metal ion studies reportedly identified

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

  MAUDE report 50473055 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50225717 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND HAD A HIP REVISION ON (B)(6) 2023. OPERATIVE NOTES INDICATED BLACK-COLORED SYNOVIAL FLUID AND THE CAPSULE WAS COATED IN A RIND OF ADVERSE LOCAL TISSUE REACTION/METALLOSIS. DOI: (B)(6) 2010. DOR: (B)(6) 2023. LEFT HIP.

  Patient problems: Foreign Body Reaction; Swelling/ Edema

  MAUDE report 19959943 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY, AND THE STEM, HEAD, AND LINER WERE REMOVED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2012; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17788069 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 11, 2023Naturally Worn; Naturally Worn

  LITIGATION RECORDS AD (B)(6) 2023 ALLEGES PATIENT SUFFERED OF HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RELEASED BY THE PINNACLE HIP REPLACEMENT, RESULTING IN INJURY DECREASED LONGEVITY, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN, BONE DESTRUCTION, METAL WEAR, AND TOXIC HEAVY METAL POISONING, MOREOVER, INCURRED MEDICAL EXPENSES AND EXPECTS TO EXPERIENCE EMOTIONAL DISTRESS. DOI: 2008 DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching; Distress; Loss of Range of Motion; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 16909950 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT HIP. DOI: (B)(6) 2008, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16776802 ↗
• InjuryApr 3, 2023Corroded; Naturally Worn; Corroded; Naturally Worn

  UPDATED EVENT DESCRIPTION: DURING THE REVISION PROCEDURE, SIGNIFICANT CLOUDY JOINT EFFUSION CONSISTENT WITH REACTION TO A METAL-ON-METAL BEARING, SMALL AMOUNT OF CORROSION AT THE HEAD NECK JUNCTION ON THE STEM, WELL FIXED COMPONENTS, LARGE ANTERIOR OSTEOPHYTE. THE HIP WAS ASPIRATED OF CLOUDY JOINT FLUID CONSISTENT WITH A METAL-ON-METAL BEARING. THERE WAS SOME SYNOVITIS, CONSISTENT WITH A METAL-ON-METAL BEARING. DOI: (B)(6) 2009, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 16663506 ↗
• InjuryMar 13, 2023Naturally Worn; Naturally Worn

  AFTER A REVIEW OF MEDICAL RECORDS, IT WAS NOTED THAT THERE WAS SIGNIFICANT OSTEOLYSIS OF THE PROXIMAL FEMUR. HIP CAPSULECTOMY WAS DONE AND DURING THIS PROCESS, A LARGE SIGNIFICANT AMOUNT OF WHITE HEMATURIA WAS EXPRESSED FROM THE JOINT. THERE WAS EXTREMELY HIGH PRESSURE. SIGNIFICANT TRUNNIONOSIS OF THE FEMORAL TRUNNION WITH THE FEMORAL HEAD, SIGNIFICANT METALLOSIS WITH TRUNNIONOSIS. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 16528940 ↗

Other Depuy (Ireland) products

• ATTUNE1,475 models · 41,078 reports · 35 recalls
• QUICKSET66 models · 21,038 reports
• PINNACLE198 models · 7,240 reports
• DELTA XTEND194 models · 5,353 reports
• P.F.C. SIGMA487 models · 5,192 reports · 1 recall
• INHANCE202 models · 4,578 reports
• SMARTSET7 models · 4,415 reports
• SIGMA380 models · 3,831 reports