AML 1554-02-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295058373), received between Aug 23, 2017 and Jul 1, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Corroded” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 6, 2021Degraded; Degraded

  PINNACLE LITIGATION RECORDS RECEIVED. RECORDS ALLEGES SERIOUS INJURY, ECONOMIC LOSS AND PAIN. DOI: (B)(6) 2005; DOR: (B)(6) 2020 ; RIGHT HIP. BILATERAL. SEE (B)(4) FOR LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hearing Impairment; Synovitis

  MAUDE report 12932716 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNFILED CLAIM AND PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN AND FAILURE OF MECHANICAL RIGHT TOTAL HIP ARTHROPLASTY. OPERATIVE FINDINGS SUGGESTION OF TROCHANTERIC BURSITIS WITHOUT PRESENCE OF PSEUDOTUMOR. OPERATIVE NOTE REPORTED SOME ATTENUATION IN THE FASCIA RIGHT TROCHANTER. PREVIOUS ABDUCTOR REPAIR NOT COMPLETELY HEALED, THERE WAS NEW EROSION AND LARGE AMOUNT OF FLUID. PATHOLOGY REPORT EVIDENCE OF TROCHANTERIC BURSITIS. DOI: (B)(6) 2011; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Impaired Healing; Inflammation; Pain; Pocket Erosion; Swelling/ Edema

  MAUDE report 12916500 ↗
• InjuryJan 7, 2021Osseointegration Problem; Osseointegration Problem

  THIS PATIENT'S HIP WAS REVISED DUE TO LOOSENING OF THE PRIMARY AML STEM AT THE BONE TO CEMENT INTERFACE (NON CEMENTED) AND DUE TO THE LACK OF BONE INGROWTH OF THE STEM. THE SURGEON SAID THERE WAS NO ISSUE WITH THE STEM ITSELF, THE PATIENT'S BONE JUST NEVER GREW INTO IT. NO SURGICAL DELAY NOTED. DOI: UNKNOWN; DOR: (B)(6) 2020 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 11133960 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: DER STATES THAT THE PATIENT IS INCLUDED IN THE ASR CUP RECALL. THE CUP WAS REMOVED FOLLOWING THE PROTOCOL. DOI: (B)(6) 2009; DOR: (B)(6) 2017; LEFT HIP. THIS PC IS LINKED TO (B)(4).

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8802336 ↗
• InjuryApr 18, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE AND PAIN. DOI: (B)(6) 2009; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8528462 ↗
• InjuryApr 15, 2019Corroded; Degraded; Corroded; Degraded

  LITIGATION PAPERS ALLEGE: PATIENT IS A SURGICAL RECIPIENT OF A DEPUY PINNACLE METAL-ON-METAL TOTAL HIP REPLACEMENT SYSTEM. CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BODY. PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT AND INFLAMMATION IN THE AREA OF THE IMPLANT. PATIENT ALSO EXPERIENCED DISLOCATION, DISARTICULATION, AND/OR A SLIPPING FEELING IN THE HIP JOINT AND A SENSATION THAT IMPLANT COULD NOT SUPPORT THEIR WEIGHT. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METALLOSIS. DOI: (B)(6) 2006; DOR: (B)(6) 2011, (LEFT HIP).

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8515215 ↗
• InjuryMar 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT. UPDATE AD 31 JUL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF, STICKER SHEETS AND IMPLANT RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP AND STEM.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inadequate Osseointegration; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8421082 ↗
• InjuryOct 26, 2018Corroded; Biocompatibility; Corroded; Biocompatibility

  LITIGATION PAPERS ALLEGE THAT CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENTS BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER LEFT THIGH AND HIP AREA, AS WELL AS HER GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HER LEFT HIP. UPDATE 01 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS. THERE IS NO NEW ALLEGATION.

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 8010086 ↗
• InjuryOct 10, 2018Corroded; Biocompatibility; Corroded; Biocompatibility

  LITIGATION PAPERS ALLEGE THAT CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER RIGHT AND LEFT THIGH AND HIP AREA, AS WELL AS HER GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HER RIGHT AND LEFT HIP. UPDATE AD 1 MAY 2018: THE UNKNOWN DEPUY PINNACLE HIP THAT WAS REPORTED IN (B)(4) WAS UPDATED TO PINNACLE METAL LINER. ADDED HEAD AND STEM DUE TO A LARGE AMOUNT OF TOXIC COBALT CHROMIUM IN THE PATIENT BLOOD. ADDED LAW FIRM IN THE FACILITY NAME AND UPDATED THE ASSOCIATED CONTACT.

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 7951168 ↗
• InjuryOct 10, 2018Corroded; Degraded; Biocompatibility; Corroded; Degraded; Biocompatibility

  LITIGATION PAPERS ALLEGE THAT CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER RIGHT AND LEFT THIGH AND HIP AREA, AS WELL AS HER GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HER RIGHT AND LEFT HIP. UPDATE AD 1 MAY 2018: THE UNKNOWN DEPUY PINNACLE HIP THAT WAS REPORTED IN ETQ WAS UPDATED TO PINNACLE METAL LINER. ADDED HEAD AND STEM DUE TO A LARGE AMOUNT OF TOXIC COBALT CHROMIUM IN THE PATIENT BLOOD.

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 7951085 ↗
• InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE DISTAL TO THE STEM. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 7909482 ↗
• InjurySep 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING, SWELLING, AND ELEVATED METAL ION LEVELS. DOI: (B)(6) 2007; DOR: NONE REPORTED; (LEFT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 12/17/12 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 26 APR 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. THERE WERE NO NEW ALLEGATIONS FOUND IN THE PPF. ADDED THE STEM TO THE IMPACTED PRODUCTS TO ADDRESSED PREVIOUS ALLEGATION OF ELEVATED METAL IONS. UPDATED PATIENT CODES. DOI: (B)(6) 2007; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling; Test Result

  MAUDE report 7868056 ↗
• InjuryMay 21, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE APR 23, 2018: PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENTS BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT SUFFERED FROM PAIN, DISCOMFORT, PERSONAL INJURIES AND DAMAGES, MENTAL PAIN, INFLAMMATION AND TISSUE AND BONE LOSS AND OTHER RELATED DISEASES. ADDED STEM DUE TO ALLEGED TOXIC COBALT-CHROMIUM METAL ION LEVELS. UPDATED THE REVISION HOSPITAL AND ADDED NEW ASSOCIATED CONTACT. DOI: (B)(6) 2008; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Inflammation; Injury; Not Applicable; Pain

  MAUDE report 7530540 ↗
• InjuryMay 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS. DOI 2009 - DOR (B)(6) 2012; (LEFT HIP). UPDATE: 6/5/13 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND HEARING LOSS. DATE OF IMPLANT HAS ALSO BEEN PROVIDED. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. UPDATE: 12/3/2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. COMPLAINT WAS UPDATED ON (B)(6) 2013. THE (B)(4) IS A REOPEN OF (B)(4) DUE TO RECEIPT OF THE FOLLOWING INFORMATION: UPDATE APR 18, 2018: PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS CONFIRMED IN MEDICAL RECORDS. THERE WERE NO MEDICAL RECORDS PROVIDED. UPDATED THE REVISION HOSPITAL AND ADDED FIRM TO THE COMPLAINT. UPDATED THE MANUFACTURE DATES AND ADDED EXPIRY DATES FOR THE HEAD AND LINER PRODUCTS. ADDED NEW ASSOCIATED CONTACT ADDED NEW ASSOCIATED CONTACT AND STEM PRODUCT DUE TO THE ALLEGED METAL POISONING. DOI: (B)(6) 2009 : DOR: (B)(6) 2012; (LEFT HIP). P

  Patient problems: No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7525285 ↗
• InjuryOct 18, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, POPPING/SNAPPING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES. UPDATE: 2/27/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE SEP 18, 2017: LITIGATION RECORD RECEIVED. THERE IS NO NEW ALLEGATION. ADDED COMPLAINANT INFORMATION. ADDED STEM DUE TO ALLEGED TOXIC METAL IONS. UPDATED PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON OCT 5, 2017.

  Patient problems: Loss of Range of Motion; No Code Available; Tissue Damage

  MAUDE report 6957826 ↗
• InjuryAug 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6815449 ↗