SOLUTION SYSTEM 1257-55-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295019923), received between Oct 26, 2017 and Nov 11, 2025 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(6), 70-YEAR-OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 23526192 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED RIGHT THA. REMOVED THE CONSTRAINED LINER, TWO 5.0 PERIPHERAL SCREWS. REPLACED WITH A NEW CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19994179 ↗
• InjuryOct 31, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION OF HARDWARE DUE TO LOOSE CUP. DOI: (B)(6) 2021. DOR:(B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15699563 ↗
• InjuryOct 18, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS MIGRATION AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CANCER PATIENT. CONVERTED TO TRI-FLANGE. PROXIMAL FEMUR AND SEGMENT REMOVED TO RE-ESTABLISH LEG LENGTH. DOI: (B)(6) 2018,. DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12646629 ↗
• InjuryOct 18, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS MIGRATION AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CANCER PATIENT. CONVERTED TO TRI-FLANGE. PROXIMAL FEMUR AND SEGMENT REMOVED TO RE-ESTABLISH LEG LENGTH. DOI: (B)(6) 2018, DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12646627 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGED PAIN AFTER FIRST REVISION.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9202986 ↗
• InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGED PAIN AFTER FIRST REVISION.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9172907 ↗
• InjuryJun 20, 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 RECURRENT SUPERFICIAL HEMATOMA. THE PATIENT HAD PREVIOUSLY UNDERGONE 5 TO 6 ASPIRATIONS TO TREAT THE HEMATOMA. OPERATIVE FINDINGS INCLUDE A LARGE HEMATOMA AND A RENT IN THE DEEP TISSUE ANTERIOR TO THE TROCHANTER AND EXTENDING INTO THE DEEP AREA OF THE HIP. DOI: (B)(6) 2010 - DOR: NO REVISION - DOE: (B)(6) 2011 (LEFT HIP).

  Patient problems: Hematoma; No Code Available

  MAUDE report 8716726 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLAIM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION WITH BONE ALLOGRAFTING. OPERATIVE NOTE REPORTED A LARGE ABSCESS IN THE SUBCUTANEOUS TISSUE, DEAD TISSUES AND PUS IN THE ACETABULAR COMPONENT. DEAD BONE WERE REMOVED FROM THE FEMUR; HOWEVER, STEM WAS INTACT THUS LEFT IN SITU. ANTIBIOTIC SPACER WAS IMPLANTED INTO THE AFFECTED SIDE. DOI: (B)(6) 2008; DOR: (B)(6) 2009; LEFT HIP.

  Patient problems: Abscess; Injury; Necrosis; No Code Available; Tissue Damage; Unspecified Infection

  MAUDE report 8544030 ↗
• InjuryMar 20, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  PFS ALLEGES PAIN, INSTABILITY, AND RECURRENT ABSCESSES, AND USING CANE FOR MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING. GROSS PATHOLOGY REPORTED OF A LARGE VOLUME SYNOVIAL FLUID WITH CONSISTENT SYNOVITIS, METALLOSIS, METALLIC DEBRIS, BROKEN RIM FIT SCREW ONLY ONE OF FOUR SCREW, GROSS LOOSENING OF CUP. OPERATIVE REPORT CUP HAD A VERTICAL ALTITUDE WITH GROSS ANTEVERSION AND HAD MIGRATED. LOOSENING CONFIRMED. ONE BROKEN SCREW WERE READILY IDENTIFIED AS BROKEN INVOLVING THE LIPPED PORTION OF THE CUP AND DEMONSTRATED WITH GROSS METALLOSIS AND GRAY STAINED. DOI: (B)(6) 2012; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8435674 ↗
• InjuryMar 20, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  PFS ALLEGES PAIN, INSTABILITY, AND RECURRENT ABSCESSES, AND USING CANE FOR MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING. GROSS PATHOLOGY REPORTED OF A LARGE VOLUME SYNOVIAL FLUID WITH CONSISTENT SYNOVITIS, METALLOSIS, METALLIC DEBRIS, BROKEN RIM FIT SCREW ONLY ONE OF FOUR SCREW SCREW, GROSS LOOSENING OF CUP. OPERATIVE REPORT CUP HAD A VERTICAL ALTITUDE WITH GROSS ANTEVERSION AND HAD MIGRATED. LOOSENING CONFIRMED. ONE BROKEN SCREW WERE READILY IDENTIFIED AS BROKEN INVOLVING THE LIPPED PORTION OF THE CUP AND DEMONSTRATED WITH GROSS METALLOSIS AND GRAY STAINED. DOI: (B)(6) 2012; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8435667 ↗
• InjuryNov 26, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION PAPERS ALLEGE THAT AFTER 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 THE PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER LEFT THIGH AND GROIN. SHE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (RIGHT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 10/15/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF A LOOSE CUP, A BROKEN SCREW AND METALLOSIS. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE 03 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR. ADDED STEM AND SCREWS. UPD

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 8103197 ↗
• InjurySep 11, 2018Loss of Osseointegration; Loss of Osseointegration

  SURGERY, PATIENT BEGAN SUFFERING FROM PAIN AND DISCOMFORT IN HIS HIP. DOI: (B)(6) 2007 - DOR: (B)(6) 2009 (RIGHT HIP). UPDATE AD 26 APR 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS.  IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF THE CUP AND FRACTURE OF A COMPONENT. THE STEM WAS ADDED TO THE IMPACTED PRODUCT AS IT WAS REMOVED DURING THE REVISION SURGERY. PART/LOT NUMBERS AND PATIENT INFORMATION WERE PROVIDED IN THE PPF. DOI: (B)(6) 2007 - DOR: (B)(6) 2009 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7866831 ↗
• InjuryOct 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON HAS OBSERVED THAT THIS IMPLANT HAS UNSCREWED FROM A PERIPHERAL SCREW HOLE ON A PINNACLE REVISION CUP.

  Patient problems: No Information

  MAUDE report 6982605 ↗