SOLUTION SYSTEM 1572-02-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295061465), received between Mar 15, 2019 and May 2, 2023 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2021: PATIENT HAS A CONSULT REGARDING HIS RIGHT HIP WITH PERSISTENT SWELLING THAT HAS OCCURRED NEARLY A YEAR AFTER HIS REVISION. HE HAS BEEN ASPIRATED SEVERAL TIMES WITH NO SIGNS OF INFECTION. CHROMIUM AND COBALT LEVELS ARE NORMAL. HE HAS SOME NUMBNESS AND PAIN RADIATING DOWN THE BACK OF HIS LEG. MRI SHOWS A VERY LARGE PSEUDOTUMOR AROUND THE RIGHT HIP THAT HAS RECURRED, AS WELL AS POSSIBLE LOOSENING OF THE RIGHT CUP. X-RAY REVIEW SHOWS OSTEOLYSIS AROUND THE STEM PROXIMALLY ON THE MEDIAL SIDE. (B)(6) 2022: PHYSICAL THERAPY NOTE INDICATES, PATIENT HAD A SECOND PSEUDOTUMOR REMOVAL FROM HIS HIP ON (B)(6) 2021. HE HAS WEAKNESS AND DIFFICULTY WALKING REQUIRING PHYSICAL THERAPY TREATMENTS. IT IS UNKNOWN IF ANY IMPLANTS WERE REVISED. (B)(6) 2022: PATIENT CANCELS PHYSICAL THERAPY VISITS, DUE TO EXCESSIVE ¿POPPING SOUNDS¿ IN HIS HIP. DOI: (B)(6) 2020. DOR: UNKNOWN. RIGHT HIP SECOND COMPLAINT.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Fatigue; Hypersensitivity/Allergic reaction; Metal Related Pathology; Numbness; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16852330 ↗
• MalfunctionJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, VISIT NOTES ON (B)(6) 2018 INDICATED THAT PATIENT HAD COMPLAINTS OF OCCASIONAL STIFFNESS AND SORENESS. VISIT NOTES ON (B)(6) 2019 REPORTED THAT PATIENT HAD A LOWER LUMBAR PAIN BILATERAL LOWER EXTREMITY PAIN INTO THE POSTERIOR THIGH, QUAD AND POSTERIOR CALVES. UROLOGIST CONSULTATION REPORTED THAT PATIENT PROSTATE WAS ENLARGE. DOI:(B)(6) 2009 (CUP). DOI: (B)(6) 2017; DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fatigue; Muscular Rigidity; Pain

  MAUDE report 16213749 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORD RECEIVED. PATIENT ALLEGES PAIN, ELEVATED METAL ION, FATIGUE, TUMOR THAT CAUSED BY METALLOSIS DUE TO THE INITIAL IMPLANT OF THE METAL-ON-METAL PINNACLE DEVICE, HEMARTHROSIS, NUMBNESS AND DISCOMFORT, FLUID ACCUMULATION, BLEEDING INTO THE HIP JOINT, AND SWELLING. PATIENT DEVELOPED A FOOTBALL-SIZED PSEUDOTUMOR AND RELATED NECROSIS, CAUSED BY METALLOSIS DUE TO THE INITIAL IMPLANT OF THE METAL-ON-METAL PINNACLE DEVICE CAUSING HIM EMOTIONAL DISTRESS. PLAINTIFF SUSTAINED AND CONTINUES TO SUFFER DAMAGES, INCLUDING, BUT NOT LIMITED TO SUFFERING, SEVERE AND POSSIBLY PERMANENT INJURIES, DISABILITY, DISFIGUREMENT, ECONOMIC DAMAGES (INCLUDING MEDICAL AND HOSPITAL EXPENSES) MONITORING, REHABILITATIVE AND PHARMACEUTICAL COSTS, AND LOST WAGES AND LOSS OF FUTURE EARNINGS CAPACITY, INABILITY TO WALK WITHOUT A CANE, BONE LOSS, PARASTHESIA IN RIGHT LEG, MARK DISTENTION IN RIGHT HIP, DEBRIS, KIDNEY CANCER, THYROID ISSUES, BELL'S PALSY, AND VERTIGO. DOI: (B)(6) 2005; DOR: (B)(6) 2020 ; (RIGHT HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Necrosis; Numbness; Osteolysis; Pain; Paresthesia; Physical Asymmetry; Pocket Erosion; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury; Vertigo; Wound Dehiscence

  MAUDE report 13306544 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2009, (RIGHT HIP). THIS PC IS FOR THE FIRST REVISION OF THE RIGHT HIP.

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

  MAUDE report 8424642 ↗