AML 1554-01-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295058236), received between Aug 1, 2017 and Aug 14, 2024 — classified as 16 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION STATED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC JOINT INFECTION STATUS POST-EXPLANTATION ANTIBIOTIC CEMENT SPACER PLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Limb Fracture; Nerve Damage; Swelling/ Edema; Unspecified Infection

  MAUDE report 12316412 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2009, DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11349760 ↗
• InjuryJan 6, 2021Degraded; Degraded

  IT WAS REPORTED THAT THE HEAD AND LINER EXCHANGE DUE TO PAIN. METAL LINER AND HEAD WERE REMOVED AND REPLACED WITH A POLY LINER AND DELTA REVISION HEAD. DOI: UNKNOWN. DOR: (B)(6) 2020 (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 11122976 ↗
• InjuryJan 6, 2021Degraded; Degraded

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS METALLOSIS. REVISION NOTES STATED THAT A RUSH OF FLUID WAS SEEN WHICH WAS BROWN AND CONSISTENT WITH METAL REACTION FLUID. THE HEAD WAS DISIMPACTED FROM THE TRUNNION AND THERE WAS SHOWN TO BE CORROSION ON THE TRUNNION ITSELF. LINER WAS REMOVED. PATIENT EXPERIENCED PAIN AND DISCOMFORT. DOI: (B)(6) 2010 - DOR: (B)(6) 2020 (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Pain

  MAUDE report 11122951 ↗
• InjuryNov 10, 2020Migration; Migration

  IT WAS REPORTED THAT HIP REVISION DUE TO STEM SUBSIDENCE. DOI: (B)(6) 2007, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10817939 ↗
• InjuryMar 9, 2020Loss of Osseointegration; Loss of Osseointegration

  UPDATE OCT. 5, 2017: LITIGATION RECORD RECEIVED. LITIGATION ALLEGES PAIN, WEAKNESS AND DIFFICULTY WITH SIMPLE LIVING ACTIVITIES. UPDATE FEB. 21, 2020: AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO WEAR OF ARTICULAR WEIGHT-BEARING SURFACE, PAIN AND LOOSENING OF THE FEMORAL STEM. RADIOGRAPHS SHOWED NO SIGNS OF LOOSENING AND THE STEM APPEARED TO BE SPOT-WELDED IN SEVERAL SPOTS. THE PATIENT'S COBALT CHROMIUM LEVELS WERE ELEVATED. OPERATIVE NOTES INDICATE THAT THERE WAS A LOT OF SCARRING, THE STEM WAS ROTATIONALLY LOOSE. DOI: (B)(6) 2010; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Adhesion(s); Inadequate Osseointegration; No Code Available; Pain; Weakness

  MAUDE report 9808392 ↗
• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC. REVISION NOTES REPORTED THAT THERE WAS EXTENSIVE HETEROTOPIC OSSIFICATION, EVIDENCE OF THE EFFECTS OF EXTENSIVE METAL DEBRIS WITH GRAY APPEARANCE TO THE TISSUES. AS EXPECTED IN THE AREA OF THE CALCAR, EXTENSIVE GRAY COLORED DEBRIS WAS NOTED. AFTER THE ACETABULAR METAL LINER WAS REMOVED, THERE WAS AN AREA POSTERIOR SUPERIORLY WHERE IT APPEARS MOST OF THE WEAR HAD OCCURRED. CLINICAL VISITS REPORTED PAIN, METALLOSIS, LIMITED MOBILITY, LOCKING SENSATION IN BOTH HIPS AND FINDINGS CONSISTENT WITH ALVAL. LABORATORY RESULT FOR COBALT-CHROMIUM SHOWS ELEVATED METAL ION LEVEL. DOI: (B)(6) 2009 - DOR: (B)(6) 2018, (LEFT HIP). PLEASE SEE (B)(4) FOR THE RIGHT HIP.

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

  MAUDE report 8880204 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS METAL-ON-METAL TOTAL HIP ARTHROPLASTY WITH ELEVATED METAL ION LEVELS. REVISION NOTES REPORTED THAT THERE WAS SOME BLACKENING OF THE PERICAPSULAR TISSUE. HEAD AND LINER WERE REMOVED. CLINICAL VISITS REPORTED BILATERAL HIP PAIN, HETEROTOPIC OSSIFICATION, LIMITED MOBILITY, LOCKING SENSATION IN BOTH HIPS, METAL ON METAL ARTICULATION AND FINDING IS CONSISTENT WITH ALVAL. LAB RESULTS FOR METAL IONS WERE ABOVE 7. FINDINGS FROM REVISION: SYNOVIAL FLUID WAS STRAW-COLORED. THERE WAS SOME CHANGES OF THE SYNOVIUM CONSISTENT WITH METAL WEAR. NO PSEUDOTUMOR FORMATION WAS NOTED. THERE WAS NO CLEAR EVIDENCE OF TRUNNIONOSIS. DOI: (B)(6) 2009 - DOR: (B)(6) 2018, (RIGHT HIP).

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

  MAUDE report 8874224 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS AFTER FIRST REVISION. (LEFT HIP).

  Patient problems: Test Result

  MAUDE report 8556026 ↗
• InjuryApr 15, 2019Loss of Osseointegration; Biocompatibility; Osseointegration Problem; Loss of Osseointegration; Biocompatibility; Osseointegration Problem

  PFS ALLEGES WALKING DIFFICULTY. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR PAINFUL HIP ARTHROPLASTY. OPERATIVE NOTES REPORTED THAT A RETURN OF DARK YELLOW FLUID WAS NOTED. THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE, NO BONY GROWTH AT ALL. AT THIS POINT A DECISION WAS MADE TO TREAT THE PATIENT AS INFECTED DESPITE NORMAL ESR AND CRP DE TO COLLECTED FLUID AND TISSUE SAMPLES. LAB RESULT FOR COBALT AND CHROMIUM WERE BELOW 7 PPB.

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

  MAUDE report 8514071 ↗
• InjuryMar 1, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 10 JUL 2018: RECEIPT OF PPF AND IMPLANT RECORDS. PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS BEFORE FIRST REVISION.

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

  MAUDE report 8381559 ↗
• InjuryDec 6, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES LOOSENING OF THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8137317 ↗
• InjuryOct 27, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Pain

  MAUDE report 6983554 ↗
• InjurySep 14, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. LOOSENING WAS DUE TO FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6865193 ↗
• InjuryAug 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUL 5, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES VERY HIGH CHROMIUM AND COBALT LEVELS IN THE BLOOD, MASSIVE INFECTION ((B)(6) AND GROUP B STREP), AND RENAL FAILURE DUE TO ANTIBIOTIC THERAPY. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PRESUMPTIVE INFECTION. THE PATIENT PRESENTED RIGHT HIP DRAINAGE, INFECTION (07/13/2012). REVISION NOTE STATED THAT THERE WAS NO PUS, NO ABSCESSES OR DEVITALIZED TISSUES, NO EVIDENCE OF INFECTION. CULTURE REPORT TAKEN ON (B)(6) 2012 SHOWS (B)(6). LABORATORY VALUES FOR COBALT AND CHROMIUM WERE BELOW 7PPB. THIS COMPLAINT WAS UPDATED ON: JUL 26, 2017.

  Patient problems: Bone Fracture(s); No Code Available; Pain; Unspecified Infection

  MAUDE report 6757563 ↗