AML 1554-02-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295058342), received between Aug 1, 2017 and May 3, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2021Fracture; Fracture

  A) THERE WAS NO SURGICAL DELAY DURING THE REVISION. B) PREVIOUS REVISION PRODUCT DETAILS: AML FEMORAL STEM, 12.0MM LARGE STAT, PART NUMBER: 155402120, LOT: 747576. 32MM +9 ARTICULEZE FEMORAL HEAD PART NUMBER: 136523000, LOT: 9457479. PROSTALAC ACETABULAR CUP PART NUMBER: 154142320, LOT: J3068M. C) PRODUCTS EXPLANTED ASIDE FROM THE STEM: 32MM +9 ARTICULEZE FEMORAL HEAD PART NUMBER: 136523000, LOT: 9457479. PROSTALAC ACETABULAR CUP PART NUMBER: 154142320, LOT: J3068M. D) THE CEMENT WAS NOT MANUFACTURED BY DEPUY. E) NO, THE EXPLANTED STEM DID NOT BREAK INTO TWO OR MORE PIECES. IT CAME OUT IN ONE PIECE AND REMAINED IN ONE PIECE. F) THE AFFECTED SIDE IS THE PATIENT¿S LEFT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Limb Fracture

  MAUDE report 11760178 ↗
• InjuryFeb 3, 2020Malposition of Device; Malposition of Device

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED MECHANICAL DERANGEMENT OF ORTHOPEDIC DEVICE. OPERATIVE NOTES INDICATED CLICKING. THERE WAS SOME METALLIC WIRE DEBRIS. THE BASE OF THE NECK OF THE PROSTHESIS OF THE FEMUR WAS TOUCHING UP AGAINST THE RIM OF THE ACETABULUM. HAD A 30 DEGREES ANTEVERSION OF HIS FEMUR AND 25 DEGREES OF HIS ACETABULUM BUT THIS COMBINATION WAS ENOUGH TO CAUSE THIS IMPINGEMENT. DOI: (B)(6) 2007; DOR: (B)(6) 2011 RIGHT HIP.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 9660511 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, IT WAS INDICATED THAT DURING THE PRIMARY SURGERY, AS THE REAL STEM WAS BEING IMPACTED, A SMALL ANTERIOR UNICORTICAL CRACK OCCURRED ON THE FEMUR. A CERCLAGE CABLE WAS THEN PLACED AROUND THE PROXIMAL FEMUR. THE STEM WAS NOTED TO BE STABLE. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8528519 ↗
• InjuryJun 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION PAPERS ALLEGE THAT AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PLAINTIFF'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS BOTH THIGH AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. IT IS FURTHER ALLEGED THE PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. DOI: (B)(6) 2004 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Injury; Pain; Test Result; Tissue Damage

  MAUDE report 7574592 ↗
• InjuryMay 8, 2018Adverse 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 PAIN AND ELEVATED METAL ION LEVELS. **UPDATE: 9/10/13 - AMENDED LITIGATION PAPERS RECEIVED. ORIGINAL LITIGATION INDICATED THAT THE PATIENT WAS IMPLANTED WITH ASR; HOWEVER, AMENDED LITIGATION ALLEGES THAT THE PATIENT WAS IMPLANTED WITH PINNACLE. PART AND LOT INFORMATION HAS BEEN LOCATED THROUGH AN INVOICE SEARCH. THE PRODUCTS HAVE BEEN UPDATED AND FOLLOW-UPS CREATED. **UPDATE: (B)(6) 2013 DER RECEIVED WITH DOR OF (B)(6) 2013 UPDATE REC'D 2/5/2014- PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS GIVEN. AFTER REVIEW OF THE PRIMARY AND REVISION OPERATIVE NOTES THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 02/05/14. (B)(4) IS A REOPEN OF (B)(4) DUE TO RECEIPT OF THE FOLLOWING INFORMATION; UPDATE APR 10, 2018: PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR AND METALLOSIS. UPDATED THE REVISION HOSPITAL. ADDED STEM PRODUCT DUE TO THE ALLEGED ELEVATED METAL ION LEVEL. DOI: (B)(6) 2008 : DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7493663 ↗
• InjuryMar 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INITIAL PROCEDURE, (B)(6) 2008 : LEFT TOTAL HIP REPLACEMENT. PATIENT WAS ORIGINALLY IMPLANTED WITH SIZE 46 ASR UNIPOLAR FEMORAL COMPONENT, ASRTAPER SLEEVE ADAPTOR AND SIZE 52 ASR TOTAL ACETABULAR COMPONENT. PREOPERATIVE DIAGNOSIS-SEVERE LEFT COXARTHROSIS (PRIOR TO (B)(6) 2008 SURGERY). IT WAS REPORTED BY LEGAL THAT THE PATIENT WAS REVISED ON (B)(6) 2015 PATIENT HAD A TOTAL LEFT HIP REVISION. THE PRE-OP DIAGNOSIS WAS A PSEUDOTUMOR AND CONTAINED BONE LOSS (LEFT FEMUR AND LEFT ACETABULUM). THE SURGERY INVOLVED REMOVAL OF THE LEFT HIP PSEUDOTUMOR, REVISION OF THE ACETABULAR CAVITY, TOTAL LEFT HIP REPLACEMENT. ALLOGRAFT-LEFT ACETABULUM AND LEFT FEMUR. (B)(6) 2018: MEDICAL RECORDS AND TRANSLATED DOCUMENT RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS INDICATED THAT THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR TYPE TISSUE REACTION TO A TOTAL LEFT HIP REPLACEMENT WITH CONTAINED BONE LOSS. THE REVISION NOTES REPORT THAT WHEN THEY OPENED THE JUNCTION BETWEEN THE SCAR TISSUE AND THE POSTERIOR PART OF THE GREATER TROCHANTER, A LARGE AMOUNT OF GREENISH SEROUS FLUID WAS FOUND. AN ABNORMAL TISSUE REACTION WITH GREENISH HYPERPLASTIC TISSUE IN THE BACK OF THE HIP PROSTHESIS A

  Patient problems: Discomfort; Injury; Pain; Tissue Damage

  MAUDE report 7352390 ↗
• InjuryAug 1, 2017Adverse 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

  UPDATE OCT 24, 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PATIENT ALSO ALLEGES MACULAR DEGENERATION AND VITREAL DETACHMENT, ERRATIC THYROID BLOOD COUNTS, NERVE PAIN IN THE RIGHT FOOT AND HAND, AND AUDITORY IMPAIRMENT WHICH WERE ALL MAY BE DUE TO METALLOSIS. SURGEON ALSO STATES THAT PAIN WILL BE PERMANENT DUE TO THE EROSION OF THE EXTERNAL ROTATOR AND CAPSULE CAUSED BY METALLOSIS AND PSUEDOTUMORS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT TOTAL HIP REPLACEMENT. REVISION NOTES REPORTED EGRESS OF CLEAR STRAW COLORED FLUID, GRAY THICKENING OF THE SYNOVIUM CIRCUMFERENTIALLY AND ERODED EXTERNAL ROTATORS AND CAPSULE. THIS COMPLAINT WAS UPDATED ON: OCT 30, 2017.

  Patient problems: Foreign Body Reaction; Hearing Impairment; Host-Tissue Reaction; No Code Available; Pain; Retinal Degeneration; Vitreous Detachment

  MAUDE report 6757656 ↗