AMLRecalls & reported problems across all models

We found 23 models of AML by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 237 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2014 and Dec 2, 2025 — classified as 234 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (30 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

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

• AML 1554-01-135

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  28 reports
• AML 1554-02-135

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  24 reports
• AML 1554-01-120

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  19 reports
• AML 1554-02-150

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  19 reports
• AML 1554-01-105

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  17 reports
• AML 1554-01-121

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  16 reports
• AML 1554-01-150

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  15 reports
• AML 1554-02-165

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  14 reports
• AML 1554-03-135

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  12 reports
• AML 1554-01-106

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  11 reports
• AML 1554-01-165

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  10 reports
• AML 1554-03-150

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  9 reports
• AML 1554-02-106

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  7 reports
• AML 1554-02-120

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  7 reports
• AML 1554-03-165

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  7 reports
• AML 1554-02-121

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  5 reports
• AML 1554-03-180

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  5 reports
• AML 1554-01-180

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• AML 1554-02-105

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  3 reports
• AML 1554-02-180

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• AML 1554-02-195

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  1 report
• AML 1554-02-210

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report
• AML 1554-03-225

  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.

• InjuryDec 2, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING AND SUBSIDENCE OF FEMORAL STEM. LOOSENING INTERFACE: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23692874 ↗
• InjuryJul 1, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT AML STEM REVISED FOR LOOSENING. STEM WAS LOOSE AT NON-CEMENTED INTERFACE. IT WAS ALSO REPORTED THAT SOLUTION DRILLS WERE BROKEN. SOL SYS CEM PLUG DRILLS 6.0MM WAS BROKEN AND RETRIEVED. SOL SYS CEM PLUG DRILLS 4.5MM WAS BROKEN AND NOT RETRIEVED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22372154 ↗
• InjuryJan 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT WAS RE-IMPLANTED WITH DEPUY POLY LINER, CERAMIC HEAD AND AML STEM. DURING EXTRACTION AND RE-IMPLANTATION OF THE DEPUY AML STEM, AN INTRAOPERATIVE PERFORATION FRACTURE OF THE DISTAL FEMUR OCCURRED. THE PATIENT REQUIRED A FEMORAL STRUT ALLOGRAFT WITH 5 CERCLAGE CABLES AND A GREATER TROCHANTER PLATE TO TREAT (ALL COMPETITOR PRODUCTS). A CT SCAN ON (B)(6) 2021 REPORTS A PERIPROSTHETIC FRACTURE NON-UNION OF THE PATIENT'S LEFT FEMUR, INVOLVING CERCLAGE CABLES AND A GREATER TROCHANTER HOOK (MANUFACTURER NOT PROVIDED). THERE IS ALSO NO INFORMATION ON WHEN THE FRACTURE OCCURRED OR WHEN IT WAS INITIALLY REPAIRED. ALL LEFT TOTAL HIP PRODUCTS WERE STILL PRESENT. ON (B)(6) 2021, PATIENT'S LEFT HIP WAS REVISED TO ADDRESS A LOOSE FEMORAL STEM IMPLANT SECONDARY TO A PREVIOUS PERIPROSTHETIC AND GREATER TROCHANTER FEMUR FRACTURES, THAT HAD NOT PROPERLY HEALED AND ULTIMATELY FAILED WITH NON-UNION AND LOOSENING OF THE FEMUR IMPLANT. STEM AND HEAD WERE REVISED TO A RECLAIM STEM AND HEAD, WHILE RETAINING THE EXISTING CUP, SCREWS, AND LINER. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Malunion of Bone

  MAUDE report 21253167 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. EVERYTHING WAS REMOVED AND PROSTALAC SPACER WAS PUT IN. DATE OF INITIAL SURGERY WAS UNKNOWN. THERE WAS NO BROKEN INSTRUMENT AND NO DELAYS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20929006 ↗
• InjuryDec 2, 2024Adverse 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 THE FRACTURE OF FEMORAL STEM. DOI: (B)(6) 2007. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20818046 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEM AND LINER WERE REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 19980831 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE IMPLANTS WERE IMPLANTED IN THE RIGHT HIP ON (B)(6) 2007. REVISED ON (B)(6) 2011, FEMORAL OSTEOLYSIS, INFECTION. COBALT AND CHROMIUM ARE 14 AND 9, PAIN. ALL IMPLANTS WERE REMOVED. OSTEOTOMY WAS USED TO REMOVE THE AML STEM. PROSTALAC WAS IMPLANTED. LOOSE CUP WAS NOTED PRE-OP, BUT OPERATIVE NOTED INDICATED IT WAS EMBEDDED AND THERE WAS NO INDICATION OF LOOSENING. PICC LINE WAS PLACED FOR TREATMENT OF INFECTION. SECOND STAGE REVISION ON (B)(6) 2012 ¿ COMPETITOR STEM PLACED WITH PINNACLE CUP. DOI: (B)(6) 2007, DOR: (B)(6) 2011, RIGHT HIP.

  Patient problems: Metal Related Pathology; Osteolysis; Pain; Unspecified Infection

  MAUDE report 19624250 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW PATIENT WAS REVISED DUE TO FAILED METAL-ON-METAL TOTAL LEFT ARTHROPLASTY WITH RECURRENT DISLOCATION AND ELEVATED SERUM COBALT AND CHROMIUM. THE PATIENT ALSO HAD PSEUDOTUMOR WITH DEFICIENT ABDUCTORS WHICH WAS EXCISED. THE FEMORAL HEAD WAS REMOVED. THE FEMUR WAS DISSECTED IN PREPARATION FOR EXTENDED TROCHANTERIC OSTEOTOMY. BUR AND FLEXIBLE OSTEOTOMIES WERE USED TO BREAK UP THE BONE-IMPLANT INTERFACE. THE FEMORAL STEM WAS EVENTUALLY REMOVED. PRIOR SCAR TISSUE WAS EXCISED. AN ACETABULAR EXPLANT SYSTEM WAS USED TO REMOVE THE CUP WITH MINIMAL BONE LOSS.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Deformity/ Disfigurement; Discomfort; Distress; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Pain; Unspecified Tissue Injury

  MAUDE report 18623376 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, ELEVATED METAL IONS, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, PERSONAL AND ECONOMIC INJURIES. DOI: (B)(6) 2007; DOR: (B)(6) 2023; LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Metal Related Pathology; Pain

  MAUDE report 18430566 ↗
• InjuryNov 2, 2023Fracture; Fracture

  PATIENT WAS REVISED DUE TO TRUNION AND THE BREAKAGE OFF STEM. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18055395 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 STATES THE PATIENT IS HAVING RIGHT HIP PAIN WITH POPPING AND GRINDING (CREPITUS) WHEN EXERCISING. PATIENT WAS DIAGNOSED WITH RIGHT GREATER TROCHANTER BURSITIS AND WAS GIVEN A CORTISONE INJECTION. ON (B)(6) 2017, HE CONTINUES TO HAVE MILD PAIN WITH PALPATION OVER THE RIGHT GREATER TROCHANTER BUT ONLY RECOMMENDED INTERVENTION IS STRETCHING AND ICE. ON (B)(6) 2018, HE CONTINUES TO HAVE MILD PAIN OVER THE RIGHT GREATER TROCHANTER AFTER EXTENDED WALKING AND WILL CONTINUE STRETCHES AND ICE. ON (B)(6) 2021, THE PATIENT STATES HE HAS PAIN AND SWELLING IN HIS RIGHT HIP AND IS TREATING WITH ICE AND TYLENOL. ON (B)(6) 2022, AN ULTRASOUND SHOWS A LARGE FLUID COLLECTION IN THE AREA OF THE TROCHANTERIC BURSA. ASPIRATION AND POSSIBLE PHYSICAL THERAPY IS CONSIDERED THOUGH NO NOTES INDICATE THE ASPIRATION OCCURRED. ON (B)(6) 2022, PATIENT UNDERGOES A SERIOUS OF PHYSICAL THERAPY TREATMENTS FOR THE ONGOING SWELLING AND PAIN OVER THE RIGHT HIP. DOI: (B)(6) 2013; DOR: UNREVISED; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 17602618 ↗
• InjuryJul 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2023, DUE TO A FEMORAL STEM FRACTURE. A 6IN AML LRG STATURE 10.5 MM WAS FOUND TO BE BROKEN AND WAS REMOVED. SURGICAL DELAY IS UNKNOWN. THIS REPORT IS FOR A 6IN AML LRG STATURE 10.5 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17309272 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND REPORTED THAT ON (B)(6) 2015, THE PATIENT HAD A LEFT THR, TO ADDRESS END-STAGE JOINT DISEASE, COMPLETE JOINT DESTRUCTION, BONE-ON-BONE LEFT HIP. ON (B)(6) 2021 CHROMIUM 20.1 NG/ML AND COBALT 49.5 NG/ML. ON (B)(6) 2021 PROGRESS NOTES STATE THE PATIENT REPORTS HAVING BILATERAL HIP PAIN. DOI: (B)(6) 2015; DOE: (B)(6) 2021; LEFT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 16805941 ↗
• InjuryFeb 15, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO STEM SUBSIDED. THERE WAS NO SURGICAL DELAY. DOI - UNKNOWN. DOR - (B)(6) 2023. AFFECTED SIDE - LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16378397 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING, INJURY TO MUSCLE AND TISSUE, SUFFERED ADDITIONAL SCAR TISSUE FORMATION AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY. MOREOVER. SUFFERED INJURIES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN, INJURY CAUSED BY METALLOSIS, METAL WEAR, LOSS OF ENJOYMENT OF LIFE AND LIMITATION OF DAILY ACTIVITIES. PATIENT INCURRED MEDICAL EXPENSES AND EXPECTS TO INCUR ADDITIONAL EXPENSES IN THE FUTURE. ADDITIONALLY, HAS SUSTAINED EMOTIONAL TRAUMA AND DISTRESS, MENTAL ANGUISH AND ECONOMIC LOSSES. DOI: (B)(6) 2006. DOE/DOR: (B)(6) 2022. UNK AFFECTED SIDE (HIP).

  Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Limb Fracture; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16086586 ↗

Other Depuy Orthopaedics, Inc. products

• PINNACLE ALTRX98 models · 5,631 reports
• BIOLOX DELTA40 models · 4,995 reports · 1 recall
• PINNACLE182 models · 4,587 reports
• QUICKSET7 models · 3,790 reports
• PINNACLE POROCOAT38 models · 2,112 reports
• SUMMIT POROCOAT20 models · 1,646 reports
• PINNACLE GRIPTION57 models · 1,608 reports
• DURALOC93 models · 1,262 reports