AML 1554-02-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295058366), received between Dec 5, 2017 and Aug 23, 2023 — classified as 24 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE 13.5 LARGE AML STEM BROKE IN A TRANSVERSE PLANE 120.31MM DISTALLY FROM THE IMPLANT SHOULDER. 40+12 TS HEAD WAS IMPLANTED 1 DAY PRIOR ((B)(6) 2021) IN A HEAD AND LINER EXCHANGE (PREVIOUSLY MOM). THE HEAD WAS NOT DAMAGED NOT RE-INSERTED ONLY DUE TO SURGEONS DECISION TO DOWNSIZE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13224491 ↗
• InjuryOct 12, 2020Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT THE AML STEM FRACTURED MID-SHAFT. STEM AND HEAD REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING OF THE STEM AT THE PROXIMAL PORTION. NO SURGICAL DELAY. DOI: (B)(6) 2008; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10661814 ↗
• InjuryDec 5, 2019Naturally Worn; Naturally Worn

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO PAIN AND ELEVATED METAL IONS. OPERATIVE NOTE REPORTED STRAW COLORED FLUID PRESENT IN THE JOINT AND SLIGHTLY MURKY CONSISTENT WITH ADVERSE REACTION TO METAL DEBRIS, HYPERTROPHIC SYNOVIUM, PSEUDOTUMOR, HEMOSIDERIN STAIN, METAL STAINING AND SOME TRUNNIONOSIS. THERE WAS SOME TRUNNOINOSIS AND METAL DEBRIS ON THE TRUNNION ITSELF. ANOTHER EVENT WAS REPORTED A COMPETITOR HEAD WOULD NOT STAY ON THE TRUNNION DUE TO ADAPTOR SLEEVE SIZE WAS THE WRONG SIZE TO FIT ON THE TRUNNION. HOWEVER, DECIDED NOT TO REMOVED THE WELL FIXED STEM WHICH MAY ADD ANOTHER HOURS TO THE CASE. THE HEAD COMPONENT THAT DID NOT FIT APPROPRIATELY DURING REVISION WAS TEMPORARY LEFT IN THE PATIENT AND PROCEEDED TO A SECOND STAGE PROCEDURE TO RE-IMPLANT THE CORRECT SIZED FEMORAL HEAD (COMPETITOR). DOI: (B)(6) 2008; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Local Reaction; No Code Available; Pain; Test Result

  MAUDE report 9416803 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS. GRANULOMATOUS TISSUE, DAMAGE TO ABDUCTORS AND METALLOSIS WERE NOTED INTRAOPERATIVELY. DOI: (B)(6) 2008; DOR: (B)(6) 2019; (RIGHT HIP).

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

  MAUDE report 9415963 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN AND WEAKNESS IN HIPS AND QUADRICEPS. UPDATE AD 16 OCT 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2007. DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Pain; Test Result; Weakness

  MAUDE report 9086811 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES REVISION DUE TO ELEVATED METAL IONS. DOI: (B)(6) 2004; DOR: (B)(6) 2013, (LEFT HIP).

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Test Result

  MAUDE report 9076204 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED HIP. SURGEON REMOVED ALL COMPONENTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2015, DOI: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9035985 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL, FRACTURING HER GREATER TROCHANTER AND DISLOCATING HER HIP. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGED ELEVATED METAL IONS. THE STEM WAS ADDED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATION. DOI: (B)(6) 2013; DOR: (B)(6) 2013 (LEFT HIP); SECOND REVISION.

  Patient problems: Bone Fracture(s); Fall; Test Result

  MAUDE report 8793282 ↗
• InjuryJun 14, 2019Loss of Osseointegration; Unintended Movement; Loss of Osseointegration; Unintended Movement

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. THE PATIENT HAS HAD DIFFICULTY WITH PAIN. AFTER REVIEW OF MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED THAT THE PATIENT WAS FOUND TO HAVE OBVIOUS EVIDENCE OF A LOOSE FEMORAL COMPONENT. THERE WAS MICROMOTION PRESENT AT THE STEM. THE STEM WAS REMOVED WITH A BACK SLAP DEVICE PLACED THROUGH THE PROXIMAL HOLE WITHOUT ANY BONE LOSS. THERE WAS NO EVIDENCE OF OSTEAL INTEGRATION ALONG THE LENGTH OF THE STEM. ACETABULAR COMPONENT WAS FOUND BE WELL FIXED AND WELL POSITIONED. THERE WAS NO GROSS EVIDENCE OF INFECTION OR ANY OBVIOUS METAL - ON- METAL RESPONSE. SERIAL RADIOGRAPHS OF THE FEMORAL COMPONENT SHOWED EVIDENCE OF SUBSIDENCE AND SOME PERIPROSTHETIC LUCENCY. DOI: (B)(6) 2009; DOR: (B)(6) 2010; (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8701441 ↗
• InjuryJun 11, 2019Biocompatibility; Osseointegration Problem; Biocompatibility; Osseointegration Problem

  PFS ALLEGES LACK OF MOBILITY, LACK OF FULL RANGE OF MOTION, METALLOSIS AND EMOTIONAL DISTRESS. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FEMORAL STEM LOOSENING. DOI: (B)(6) 2009; DOR: (B)(6) 2013; LEFT HIP. (B)(4).

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 8687773 ↗
• InjuryMay 10, 2019Biocompatibility; Biocompatibility

  (B)(4). REASON FOR ORIGINAL COMPLAINT: PATIENT WAS REVISED TO ADDRESS METALLOSIS. UPDATE: 5/29/13 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES FLUID COLLECTION. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. UPDATE: 6/12/2013: PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 14 AUG 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. STEM WAS ADDED DUE TO ALLEGED ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8599978 ↗
• InjuryApr 17, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2012, (LEFT HIP).

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

  MAUDE report 8522317 ↗
• InjuryApr 4, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN AND DISCOMFORT. UPDATE REC'D 12/6/2013: PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. UPDATE AD 25 JUL 2018: RECEIPT OF PPF RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METALLOSIS, METAL WEAR, ELEVATED METAL IONS AND BONE FRACTURE.

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

  MAUDE report 8482752 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECEIVED. LITIGATION ALLEGED PAIN AND DISCOMFORT, INJURY, EMOTIONAL DISTRESS AND MENTAL ANGUISH. THEREFORE, ON (B)(6) 2013, PATIENT WAS REVISED DUE TO INSTABILITY, ABDUCTOR DEFICIENCY WITH FRAGMENTATION, AND METALLOSIS. THIS REVISION INVOLVED THE REPLACEMENT OF HEAD AND LINER. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES FRACTURE OF THE COMPONENT, METAL WEAR AND METALLOSIS. PFS HAS NO NEW ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS INSTABILITY, SYNOVITIS, ABDUCTOR DEFICIENCY WITH FRAGMENTATION AND ATROPHY OF THE GREATER TROCHANTER, METALLOSIS WITH FRACTURE OF AND FRAGMENTATION OF POLYETHYLENE AND PROXIMAL OSTEOLYSIS. REVISION NOTES REPORTED OF SYNOVITIS, MIGRATION OF THE GREATER TROCHANTERIC FRAGMENT, FRAGMENTATION AND FRACTURING OF POLY LINER WAS ENCOUNTERED WITH TWO MAIN PIECES. HOWEVER THE LINER WAS METAL. DOI: (B)(6) 2000; DOR: (B)(6) 2013; RIGHT HIP.

  Patient problems: Discomfort; Injury; No Code Available; Osteolysis; Pain; Tissue Damage

  MAUDE report 8449253 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT IMPLANT RELEASED METAL IONS INTO PATIENT'S BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS EXPERIENCED SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. PATIENT HAS ALSO EXPERIENCED AN INABILITY TO WALK, FROZEN JOINT AND CAN ONLY STAND FOR THREE MINUTES. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGED INFECTION. DOI: (B)(6) 2010, DOR: NOV. 03, 2013, (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 8137470 ↗
• InjuryOct 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION, SWELLING, DIFFICULTY AMBULATING, DIFFICULTY WEIGHT BEARING, AND ADDED STEM DUE TO ALLEGED ELEVATED METAL IONS.

  Patient problems: Discomfort; Inflammation; Pain; Swelling; Test Result

  MAUDE report 7937900 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) LITIGATION RECEIVED. LITIGATION ALLEGED INJURY, EMOTIONAL DISTRESS, PAIN, ELEVATED METAL ION LEVELS AND PSEUDOTOMOR. DOI: (B)(6) 2008; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Distress; Host-Tissue Reaction; Injury; Not Applicable; Pain; Test Result; Tissue Damage

  MAUDE report 7850583 ↗
• InjuryMay 7, 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

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: 2003; - DOR: (B)(6) 2012. (LEFT HIP). UPDATE: 8/7/2012 - LITIGATION PAPERS RECEIVED. IN ADDITION TO PAIN, IT IS ALLEGED THAT THE PATIENT HAD HIGH LEVEL IONS. DATE OF IMPLANTATION WAS PROVIDED - (B)(6) 2003. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE: 2/1/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. COMPLAINANT.

  Patient problems: No Code Available; Not Applicable; Osteolysis; Pain

  MAUDE report 7490327 ↗
• InjuryMar 22, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS DETACHMENT OF THE FEMORAL STEM AND REACTION TO METAL. OPERATIVE NOTES REPORTED OF BROWNISH TISSUE AROUND THE TOP AND BOTTOM PARTS OF THE CAPSULE, POROUS BONE PROBABLE SECONDARY TO A REACTION WITH THE METALLIC LESIONS. CLINIC VISITS REPORTED OF PAIN SINCE FALL AND REACTION TO METAL. MRI SHOWED FLUID AROUND THE TIGHT HIP. DOI: (B)(6) 2009; DOR: (B)(6) 2014; RIGHT HIP ASR. PATIENT IS BILATERAL. SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Injury; Pain

  MAUDE report 7361525 ↗
• InjuryMar 22, 2018Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  DER STATES THAT THE STEM HAD SUBSIDED AND WAS LOOSE CAUSING THE PATIENT PAIN. REMOVED HEAD AND STEM. REPLACED WITH SUMMIT CEMENTED STEM AND 36 MM PLUS 5 HEAD. DOI: (B)(6) 2013; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7361433 ↗
• InjuryDec 20, 2017Break; Fracture; Osseointegration Problem; Break; Fracture; Osseointegration Problem

  AML LITIGATION RECORDS RECEIVED ALLEGING PAIN, COMPONENT FRACTURE (STEM), MENTAL ANGUISH, PHYSICAL INJURIES, SUFFERING, MEDICAL EXPENSES, ECONOMIC LOSS, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT AND DISFIGUREMENT. DOI: (B)(6) 2009 - DOR: (B)(6) 2017; (LEFT HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Inadequate Osseointegration; No Code Available; Pain; Scar Tissue

  MAUDE report 7133050 ↗
• InjuryDec 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS ASEPTIC FAILURE LEFT THA. REVISION NOTES REPORTED A MASSIVE PSEUDOTUMOR THAT DISTENDED THE POSTERIOR CAPSULE, SHORT EXTERNAL ROTATORS AND GLUTEUS MEDIUS, GREATER THAN 300 CC OF FLUID, ACUTE LOCAL TISSUE REACTION, MASSIVE PROXIMAL FEMORAL BONE LOSS WITH COMPROMISE OF THE ABDUCTORS, CIRCUMFERENTIAL LARGE LOSS OF CONTAINED BONE BEHIND THE WELL-FIXED SHELL. PRODUCT CODES AND LOT NUMBERS WERE PROVIDED. LEFT HIP

  Patient problems: Foreign Body Reaction; Injury; Local Reaction; Osteolysis; Tissue Damage

  MAUDE report 7083933 ↗