SOLUTION SYSTEM 1257-25-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295019862), received between Oct 26, 2017 and Apr 21, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED AS ACETABULAR SHELL IMPLANT LOOSENING/ MOVEMENT. IT WAS INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11704524 ↗
• InjuryNov 14, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENTS ACETABULAR COMPONENT FAILED AND COLLAPSED INTO THE PATIENTS PELVIS. DR LES WAS UNSURE OF ORIGINAL IMPLANT DATE, BUT THE FIRST REVISION DATE WAS (B)(6) 2019. DR LES PERFORMED THAT REVISION AS WELL. THE PINNACLE REVISION CUP WAS LOOSENED AT BONE TO IMPLANT INTERFACE AND WAS TAKEN OUT, ALONG WITH THE SCREWS, LINER, AND 40MM +15.5 FEMORAL HEAD. DR LES PREPARED THE ACETABULUM FOR A 74MM REVISION PINNACLE CUP AND PLACED SEVERAL SCREWS IN TO SECURE THE CUP. A 40MM +5 FEMORAL HEAD WAS TRIALED AND FOUND TO BE SATISFACTORY. THE REAL HEAD WAS IMPLANTED AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9324314 ↗
• InjuryApr 5, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE: SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES THAT THE PATIENT FELT LIKE THERE WAS SCRAPING SENSATION IN HIS HIP, WALKING DIFFICULTY AND FALLING DOWN ON OCCASION. SURGEON RECOMMENDED REVISION SURGERY DUE TO LOOSE COMPONENT AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS CUP LOOSENING, METALLOSIS AND INSTABILITY. REVISION NOTES REPORTED THAT HIP WAS FOUND TO BE DISLOCATED, SYNOVIAL SCARRING, AND GROSSLY LOOSE CUP. IT WAS ALSO FOUND THAT THE STEM IS 20 DEGREES RETROVERTED. THE SLEEVE WAS LEFT IN PLACE AND STEM WAS ROTATED OVER 40 DEGREES TO PROVIDE APPROPRIATE ANTEVERSION THEN WAS RE-INSERTED. PATHOLOGY REPORT IS POSITIVE FOR ACUTE INFLAMMATION. LAB DATA SHOWS METAL ION LEVELS WERE ABOVE 7 PPB. DOI: (B)(6) 2007; DOR: (B)(6) 2014; (RIGHT HIP).

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

  MAUDE report 8486608 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, POPPING/SNAPPING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES. UPDATE AD 09 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION.

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

  MAUDE report 8212187 ↗
• 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 8102867 ↗
• InjuryJun 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DER STATES THAT THE CUP MOVED BUT WAS NOT LOOSE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7568897 ↗
• InjuryJun 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DER STATES THAT THE CUP MOVED BUT WAS NOT LOOSE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7568821 ↗
• InjuryMay 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND MEDICAL RECORDS RECEIVED. PLAINTIFF PROFILE FORM ALLEGES LOOSENING OF CUP, INFECTION, LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS DETERMINED THAT THE PATIENT HAD A TWO STAGE REVISION DUE TO INFECTION FROM THE PREVIOUS UNKNOWN MANUFACTURER HIP IMPLANT WITH THE FIRST STAGE REVISION TO A TOTAL DEPUY HIP. REVISION NOTES REPORTED THAT THE PATIENT UNDERWENT THE SECOND STAGE REVISION, AND ALL THE FEMORAL AND ACETABULAR COMPONENTS WERE REVISED TO A COMPETITOR HIP. THERE WERE NO INDICATIONS OF LOOSENING AND INFECTION FOR THE REVISED DEPUY IMPLANTS. DOI: (B)(6) 2007; DOR: (B)(6) 2013; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable; Unspecified Infection

  MAUDE report 7544540 ↗
• 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 6982590 ↗
• 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 6982585 ↗
• 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 6982575 ↗
• 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 6982512 ↗
• 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 6982511 ↗