SOLUTION SYSTEM 1257-30-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295019879), received between Oct 13, 2017 and Mar 6, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP WAS EXPLANTED FOR INFECTION. TEMPORARY SPACER WAS PUT IN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16488145 ↗
• InjuryJan 29, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP, DISLOCATION AND FRACTURE OF COMPONENT. ADDED CUP AND SCREWS DUE TO LOOSENING OF CUP. DOI: (B)(6) 2008 - DOR: (B)(6) 2008 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 8284508 ↗
• 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 8102949 ↗
• InjurySep 4, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS A PAINFUL LEG. A LITTLE BIT OF CORROSION WAS NOTICED INSIDE THE FEMORAL HEAD. DOI: (B)(6) 1998; (STEM & SLEEVE); (B)(6) 2010; (HEAD & LINER); DOR: (B)(6) 2012; (LEFT HIP). UPDATE AD 25 APRIL 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 PSEUDOTUMOR, LOOSENING OF CUP, INFECTION AND LOOSENING OF STEM. ADDED BONE SCREWS DUE TO ALLEGED LOOSENING OF CUP. ADDED LAWYER AND LAW FIRM. DOI: (B)(6) 2010; DOR: (B)(6) 2012; (LEFT HIP). (B)(4).

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7842014 ↗
• InjuryJul 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP COMPONENT AT BONE TO IMPLANT INTERFACE. REMOVED CUP AND LINER AND IMPLANTED NEW CUP. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7673241 ↗
• 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 7568846 ↗
• InjuryOct 13, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE ACETABULAR CUP AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Information

  MAUDE report 6949134 ↗