AMLRecalls & reported problems across all models

We found 8 models of AML by Depuy International Ltd in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2017 and Jul 2, 2024 — classified as 29 injuries.

The most frequently reported specific device problem is “Fracture” (10 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 AML problems

AML models

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

• AML 1557-03-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  8 reports
• AML 1554-03-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  5 reports
• AML 1557-02-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  5 reports
• AML 1554-02-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• AML 1554-05-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• AML 1554-04-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  2 reports
• AML 1557-04-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  2 reports
• AML 1557-07-000

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report

Recent AML adverse event reports

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

• InjuryJul 2, 2024Degraded; Degraded

  MEDICAL RECORDS RECEIVED AD 18 JUN 2024. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO ADVERSE REACTION TO METAL DEBRIS RIGHT HIP. PRIOR TO REVISION PATIENT MRI SHOWED FAILED PSEUDOTUMOR BUT SHE HAD A LARGE FLUID COLLECTION AT THE TROCHANTER WITH AVULSION OF THE ANTERIOR GLUTEI. PAIN HAS BEEN STABLE BUT INTERMITTENT IN SEVERITY AND COMPLAINTS AUDIBLE GRINDING. THERE IS A SLIGHT LIMP. OPERATIVE NOTES INDICATED UPON REMOVING THE HEAD THERE WAS A TREMENDOUS AMOUNT OF METALLIC, BLACK DEBRIS AT THE TRUNNION. DOI: (B)(6) 2006. DOR: (B)(6) 2012. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 19655664 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT HIP REVISION SURGERY. DURALOC ENDURANCE LINER WAS COMPLETELY WORN THROUGH CAUSING THE RELEASE OF METAL AND PLASTIC DEBRIS. SURGEON REPLACED CUP, LINER AND HEAD COMPONENT.

  Patient problems: Foreign Body Reaction

  MAUDE report 18864592 ↗
• InjuryOct 13, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO SURGICAL DELAY REPORTED.

  Patient problems: Discomfort

  MAUDE report 17930439 ↗
• InjuryMar 1, 2023Fracture; Fracture

  HCP IS REPORTING TO NCA/BFARM: "PAIN LEFT THIGH AND HIP SINCE YEARS. FALL IN DOMICILE ON (B)(6) 2023, THEN THE ENTIRE NIGHT LYING ON THE FLOOR. NURSING SERVICE FOUND PATIENT THE NEXT MORNING AND PICKED HIM UP. ANOTHER FALL ON (B)(6)2023. NOW PRESENTATION IN THE HOSPITAL RADEBEUL. THERE IN THE X-RAY A STEM-FRACTURE WAS DIAGNOSED. TRANSFER TO DRESDEN MUNICIPAL HOSPITAL, ORTHOPEDICS FOR FURTHER CARE. REVISION SURGERY WITH REPLACEMENT OF THE STEM ON (B)(6) 2023."

  Patient problems: Fall; Pain

  MAUDE report 16459187 ↗
• InjuryFeb 28, 2023Fracture; Fracture

  HCP IS REPORTING TO NCA/BFARM: "PRESENTATION ON (B)(6) 2022 IN EMERGENCY DEPARTMENT. REFERRAL FROM OUTPATIENT ORTHOPEDIST WITH FRACTURED HIP-TEP STEM RIGHT SIDE. THERE WAS PAIN IN THE HIP FOR OVER A YEAR. ACUTE INCREASE OF PAIN SINCE 4 WEEKS. X-RAY IN OUR AMBULANCE WITH FRACTURE OF THE STEM. HIP-TEP IMPLANTED ON THE RIGHT IN 2002 WITH TWO-STAGE REPLACEMENT IN 2003. STEM REVISION SURGERY ON (B)(6) 2023." DOI: (B)(6) 2003. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16452627 ↗
• InjuryDec 5, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  HCP IS REPORTING TO NCA/BFARM: "MS.(B)(6) WAS ADMITTED TO THE HOSPITAL VIA OUR CENTRAL EMERGENCY ROOM WITH EXISTING SEVERE PAIN SINCE THE MORNING OF (B)(6) 2022 IN THE RIGHT HIP JOINT WITH IMPLANTED HIP-TEP, AFTER SHE HAD HEARD A BANG IN THE MORNING HOURS WHILE BENDING OVER. SHE HAD BEEN MOBILE ON FOREARM CRUTCHES SINCE THEN. HIP PAIN HAD BEEN PRESENT FOR MORE THAN 2 YEARS. SINCE THE CURRENT YEAR, THEY WERE INCREASING."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15914832 ↗
• InjuryMay 6, 2022Fracture; Fracture

  AML FEMORAL STEM WAS BROKEN AND NEEDED TO BE REVISED AND REPLACED WITH A DIFFERENT STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14307594 ↗
• InjuryMay 28, 2020Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  SURGEON REPORTED TO (B)(6): "TRANSFERRAL FROM ORTHOPEDIC OUTPATIENT DEPARTMENT BECAUSE OF STEM FRACTURE - PROSTHESIS WITH SIGNS OF LOOSENING. NO TRAUMA IN ANAMNESIS. REVISION OF STEM TO MODULAR CEMENTLESS STEM WITH WIRE-OSTEOSYNTHESIS ON (B)(6) 2020."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available

  MAUDE report 10098478 ↗
• InjuryFeb 5, 2020Degraded; Degraded

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED METAL ON METAL SOFT TISSUE IRRITATION AND REACTION. OPERATIVE NOTES INDICATED INCREASING PAIN WITH A LITTLE LIMP. UPON ENTERING THE HIP JOINT ITSELF, ABUNDANT AMOUNT OF ORANGISH FLUID WAS PRESENT. NO PURULENCE BUT SORT OF THE TYPICAL METAL ON METAL REACTION. THERE WAS SOME OF USUAL REACTIVE ALMOST SAWDUST LIKE TISSUE IN THE CAPSULE. THERE WAS SOME CORROSION PRODUCTS ON THE TRUNNION BUT NO OBVIOUS DAMAGE ITSELF. DOI: (B)(6) 2004; DOR: (B)(6) 2018 LEFT HIP. PLEASE SEE (B)(4) RIGHT HIP.

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

  MAUDE report 9671327 ↗
• InjuryJul 19, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN, EXTENSIVE HETEROTOPIC BONE FORMATION, MOTION OF THE FEMORAL COMPONENT AND FOREIGN BODY REACTION. REVISION NOTES REPORTED, EXTENSIVE SCAR TISSUE AND HETEROTOPIC BONE FORMATION INFILTRATING INTO THE GLUTEUS MEDIUS AND MINIMUS. THE FEMORAL COMPONENT DID NOT APPEAR TO BE ANY BONE INGROWTH ON THE IMPLANT, BUT THERE IS EXTENSIVE SCAR GROWTH. THERE WAS GRANULATION TISSUE WITHIN THE ACETABULAR CAVITY, LIMITED RANGE OF MOTION AND LEG LENGTH DISCREPANCY. SURGICAL PATHOLOGY REPORT BENIGN, IRREGULAR FRAGMENT OF TRABECULAR BONE WITH FIBROSIS OF THE ACETABULAR TISSUE, FOREIGN BODY AND BONE FRAGMENT. DOI: (B)(6) 2002; DOR: (B)(6) 2010, LEFT HIP.

  Patient problems: Calcium Deposits/Calcification; Foreign Body Reaction; Inadequate Osseointegration; Injury; Joint Disorder; Loss of Range of Motion; No Code Available; Pain; Scar Tissue

  MAUDE report 8809035 ↗
• InjuryJul 12, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT THIS 5/8 COATED AML STEM FRACTURED PROXIMALLY WHERE THE METAPHYSEAL PORTION TAPERED DOWN TO THE STRAIGHT CYLINDER DIAPHYSEAL PART. THE STEM WAS REMOVED. THE CUP WAS RETAINED AND A NEW LINER INSERTED. IT WAS NOTED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8785130 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR ORIGINAL COMPLAINT.- PATIENT REVISED DUE TO PAIN. PPF ALLEGES INFECTION, METALLOSIS, METAL WEAR, PSEUDOTUMOR AND ELEVATED METAL IONS. DOI: (B)(6) 2003, DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8711589 ↗
• InjuryApr 3, 2019Biocompatibility; Biocompatibility

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, MULTIPLE DISLOCATIONS AND A PSEUDOTUMOR. UPDATE REC'D 7/21/2014-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PRIMARY OPERATIVE NOTE STATES A MARATHON LINER WAS IMPLANTED, BUT THE STICKER SHEET SHOWS THAT A METAL LINER WAS ACTUALLY IMPLANTED. THE PFS ALSO STATES THE PATIENT WAS REVISED ON (B)(6) 2014 FOR A PSEUDOTUMOR, BUT THERE NO MEDICAL RECORDS AT THIS TIME TO CONFIRM THIS REVISION DATE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 8/5/2014. UPDATE 1/20/2016-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED ON (B)(6) 2014 FOR INFECTION, PAIN DISLOCATION, AND CLICKING/POPPING SOUNDS. ALL IMPLANTS EXCEPT FOR THE STEM WERE EXPLANTED. THE PATIENT WAS REIMPLANTED ON (B)(6) 2014. AT THIS TIME INFECTION ISN'T ALLEGED PER LITIGATION. THE CUP AND HOLE ELIMINATOR ARE BEING ADDED TO THE COMPLAINT, BUT NOT REPORTED AS THEY WERE IMPLANTED MORE THAN 10 YEARS BEFORE BEING REMOVED. THERE WAS NO MENTION OF A PSEUDOTUMOR.

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 8478049 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION. DOI: (B)(6) 2004 - DOR: (B)(6) 2009 (RIGHT HIP).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8342865 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND ELEVATED METAL IONS. DOI (B)(6) 2003, DOR (B)(6) 2011 (LEFT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8335467 ↗

Other Depuy International Ltd products

• CHARNLEY5 models · 8 reports · 1 recall
• LCS5 models · 30 reports
• DURALOC5 models · 21 reports