SUMMIT POROCOAT 1570-01-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295059417), received between Aug 8, 2018 and Oct 27, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. THERE WAS A 20-MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708882 ↗
• InjuryMay 21, 2021Degraded; Degraded

  ASR PPD AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED LEFT TOTAL HIP REPLACEMENT SECONDARY TO LOCAL TISSUE REACTION, ASSOCIATED WITH METAL ON METAL. THERE WAS RELATIVELY LARGE CONTAINED LYTIC LESION IN THE INFERIOR ASPECT OF THE ACETABULUM. AMOUNT OF FLUID AND PSEUDOTUMOR IN THE HIP JOINT. THERE WAS A TAPER CORROSION THAT EXTENDED DISTAL TO THE TAPER WHICH EXTENDED BEYOND THE NECK OF THE FEMORAL COMPONENT, THAT IS THE CORROSION EXTENDED OUTSIDE OF THE TAPER. DOI: (B)(6) 2007. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Swelling/ Edema

  MAUDE report 11863911 ↗
• InjuryApr 29, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  MEDWATCH REPORT #MW5036483 STATES: EXPERIENCING PERIPHERAL NEUROPATHY, MEMORY LOSS, AND VARYING DEGREES OF CONSTANT PAIN FROM DEPUY PINNACLE BI-LATERAL HIP IMPLANTS. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Neuropathy; Pain; Test Result

  MAUDE report 8559968 ↗
• InjuryMar 1, 2019Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS INCREASING PAIN, RIGHT THIGH ABSCESS AND INFECTION. IT WAS STATED THAT THE PATIENT HAD INCREASING PAIN AND UNABLE TO WALK. CT SCAN SHOWED ABSCESS, LYSIS AND WAS FOUND TO HAVE MSSA BACTERIA. REVISION NOTES REPORTED, THE PATIENT'S TISSUES WERE NOTED TO BE HYPEREMIC AND EDEMATOUS. THERE WAS PURULENT OBTAINED APPROXIMATELY 300 ML AND SMALL AMOUNT WITHIN THE HIP JOINT ITSELF. THERE WAS EXTENSIVE OSTEOLYSIS ALONG THE POSTERIOR ASPECT OF THE FEMORAL STEM AND AROUND THE RIM OF THE CUP. THERE WERE APPROXIMATELY 3 VERY LARGE CYSTIC CAVITIES OF THE FLOOR OF THE ACETABULUM, FILLED WITH YELLOW APPEARING NECROTIC BONE. THERE WAS SMALL AMOUNT OF DARK STAINING OF THE FEMORAL STEM, BUT THERE WAS MINIMAL DEBRIS ON THE TRUNNION ITSELF. OPERATIVE SAMPLES NOTED ACETABULAR DEBRIS.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Cyst(s); Discomfort; Edema; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Inflammation; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Osteolysis; Pain; Swelling; Test Result; Unspecified Infection

  MAUDE report 8381924 ↗
• InjuryAug 8, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN THE STEM WAS OPENED TO PREPARE FOR IMPLANTATION, IT WAS NOTICED THAT THE STEM WAS STICKING OUT OF THE INTERIOR PLASTIC PACKAGING. THE EXTERIOR BOX HAS A SMALL HOLE IN IT. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 1 HOUR.

  Patient problems: No Code Available

  MAUDE report 7762128 ↗