SUMMIT POROCOAT 1570-11-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295060024), received between Mar 22, 2018 and Oct 24, 2023 — classified as 11 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS THREE WEEKS OUT FROM A RIGHT TOTAL HIP AND EXPERIENCED A PROXIMAL FEMORAL PERI PROSTHETIC FRACTURE. THE FEMORAL HEAD AND POROUS STEM WERE REPLACED WITH A CEMENTED STEM AND NEW FEMORAL HEAD. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17997967 ↗
• InjuryMar 28, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION COMPLETED DUE TO STEM SUBSIDED. THERE WAS NO SURGICAL DELAY. THERE WAS ALSO LOOSENING REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16632907 ↗
• InjuryJun 30, 2021Naturally Worn; Naturally Worn

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE AD 17 JUN 2021. (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PCF AND MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN, FATIGUE, DIFF WALKING, CROUCHING AND SLEEPING WITH INCREASE COBALT AND CHROMIUM LEVELS. THE PATIENT WAS THEN REVISED FOR POSSIBLE TISSUE REACTION LEFT THA, METAL ON METAL. OPERATIVE NOTES REPORTED THAT PATIENT HAS BILATERAL HIP IMPLANTS. LEFT SIDE BEEN SLIGHTLY PAINFUL. ON NOTE THERE DID NOT APPEAR TO BE ANY ADVERSE WEAR ON THE INSIDE ASPECT OF THE ACETABULAR SHELL NOR OVER THE TRUNNION OR INSIDE THE FEMORAL HEAD. NO LABS PROVIDED FOR THE ALLEGED ELEVATED METAL IONS. PATHOLOGY REPORTED OF TRUNNION LEFT HIP FOR METAL DEBRIS. ACELLULAR FIBRINOUS MATERIAL WITH SMALL NUMBER OF MICROSCOPIC PARTICLES COMPATIBLE WITH METALLIC DEBRIS. THE SPECIMEN CONSIST OF SEVERAL FRAGMENTS OF PINK-PURPLE IRREGULAR SHAPE, EVALUATE FOR ALVAL. X-RAYS REPORTED OF TROCHANTERIC BURSITIS. MRI REPORTED OF PSEUDOTUMOR, LYSIS, EFFUSION AND EROSION. DOI: (B)(6) 2011. DOR: (B

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Osteolysis; Pain; Pocket Erosion; Swelling/ Edema

  MAUDE report 12092684 ↗
• InjuryMar 9, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSE FEMORAL COMPONENT. DOI: (B)(6) 2016; DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9806317 ↗
• InjuryOct 10, 2019Migration; Migration

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9175134 ↗
• InjuryMar 29, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR AND METALLOSIS, ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: (B)(6) 2012, (LEFT HIP).

  Patient problems: Pain; Test Result

  MAUDE report 8463913 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SOFT TISSUE REACTIONS. UPDATE LITIGATION ALLEGES PAIN, DISCOMFORT, STIFFNESS, DECREASED RANGE OF MOTION, DIFFICULTY ROTATING THE HIP, DIFFICULTY BEARING WEIGHT AND DIFFICULTY AMBULATING. UPDATE IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGED ELEVATED METAL IONS; HOWEVER NO LABORATORY VALUES REPORTED. DOI: (B)(6) 2009; DOR: (B)(6) 2014 (LEFT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8366007 ↗
• InjuryJan 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PPF ALLEGES CONSTRAINED LINER, BONE FRACTURE, COMPONENT FRACTURE, DISLOCATION WITH OPEN AND CLOSED REDUCTION, INFECTION, LOOSENING OF THE STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2002 - DOR: (B)(6) 2005 (RIGHT HIP) FIRST REVISION.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Pain; Swelling; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8243670 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT METAL ON METAL CONSTRUCT WAS REVISED DUE TO PAIN AND ELEVATED METAL ION LEVEL. HEAD AND LINER WERE REVISED.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8228366 ↗
• InjuryAug 10, 2018Break; Break

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE, CONVERTING TO LONGER STEM. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7772479 ↗
• InjuryMar 22, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS STEM LOOSENING. LOOSENING OCCURRED AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7361221 ↗