SUMMIT POROCOAT 1570-01-165Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295059400), received between Jun 6, 2018 and Jan 20, 2026 — classified as 12 injuries, 1 malfunction.

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

• MalfunctionJan 20, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE IMPLANT WAS BEING OPENED WHEN A NURSE NOTICED THE TIP OF THE STEM HAD COMPLETELY PUNCTURED THROUGH THE PLASTIC PACKAGING AND THE CARDBOARD BOX, WITH NO OTHER SIGNS OF WEAR ON THE PACKAGING. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121047 ↗
• InjuryJul 2, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

  LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, SWELLING, AND IMMOBILIZATION AND ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUND THE ACETABULUM AND SYSTEMIC INJURIES. ALSO ALLEGED ARE AN EXCESSIVE LEVEL OF CHROMIUM AND COBALT. 26 SEP 2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. 7 JUN 2021 - AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO FAILED RIGHT THA, TRUNNIONOSIS, OSTEOLYSIS. OPERATIVE NOTES REPORTED THAT THERE WAS SIGNIFICANT WEAR DEBRIS AND METALLOSIS AROUND THE TRUNNION. THE STEM HAS A CORRODED TRUNNION AND WAS REMOVED. THERE WAS EXTENSIVE OSTEOLYSIS NOTED OF THE PROXIMAL FEMUR. MULTIPLE PROXIMAL FRACTURES OF THE FEMUR WERE NOTED IN THE AREAS OF EXTENSIVE LYSIS IN THE TROCHANTER AND ANTERIOR FEMUR. ALSO DUE TO THE EXTENSIVE OSTEOLYSIS AROUND THE ACETABULAR IMPLANT, POSTERIOR WALL AND ISCHIAL RIM FRACTURES WERE NOTED. IT WAS ALSO NOTED THAT THE SURGERY WAS DELAYED FOR 4 HOURS. DOI: (B)(6) 2006, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Limb Fracture; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12107791 ↗
• InjuryJun 28, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT FELL AND SUFFERED A PERIPROSTHETIC FRACTURE CAUSING THE STEM TO LOOSEN. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 12077848 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL AND FRACTURED FEMUR. REMOVED HEAD, STEM & LINER.

  Patient problems: Bone Fracture(s); Fall; No Code Available

  MAUDE report 10465091 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS ALSO REPORTED THAT THE CUP WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10334864 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE METAL ON METAL HEAD AND LINER WERE REVISED TO ADDRESS TRUNIONOSIS AND PAIN. DOI: (B)(6) 2006; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9727499 ↗
• InjuryAug 12, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF STEM AND ELEVATED METAL IONS. ADDED STEM DUE TO ALLEGED LOOSENING AND ELEVATED METAL IONS. DOI: (B)(6) 2011 - DOR: (B)(6) 2011 (LEFT HIP) 1ST REVISION.

  Patient problems: Deformity/ Disfigurement; Inadequate Osseointegration; No Code Available; Pain; Test Result

  MAUDE report 8883483 ↗
• InjuryJun 24, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORDS RECEIVED ALLEGING INJURY, ECONOMIC LOSS, LOSS OF SERVICES, EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD, PAIN, SUFFERING AND EMOTIONAL DISTRESS. DOI: (B)(6) 2008 DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Distress; Edema; Hypersensitivity/Allergic reaction; Injury; Necrosis; No Code Available; Pain; Test Result

  MAUDE report 8726443 ↗
• InjuryMar 15, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, METALLOSIS, AND DIFFICULTY WALKING. UPDATE AD 13 JUL 2018: PPF AND MEDICAL RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS AND METAL WEAR.

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

  MAUDE report 8424288 ↗
• InjuryMar 6, 2019Biocompatibility; Biocompatibility

  PATIENT WAS REVISED DUE TO CONCERNS ABOUT METAL WEAR. DOI: (B)(6) 2008; DOR: (B)(6) 2012; (RIGHT HIP). UPDATE 06/5/2012- COMPLAINT WAS RE-OPENED BECAUSE PATIENT DEMOGRAPHICS, MEDICAL RECORDS, AND X-RAYS WERE RECEIVED. OPERATIVE NOTES MADE MENTION PATIENT IS BILATERAL. NOTES CONTAIN BOTH RIGHT HIP AND LEFT HIP STICKER SHEETS. UPDATE: 8/31/2012 - LITIGATION PAPERS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. LITIGATION ALLEGES THE PATIENT SUFFERED FROM SEVERE PAIN AND DISCOMFORT. UPDATE: 12/12/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 29 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. ADDED STEM, LAWYER, LAW FIRM, REVISION HOSPITAL AND EXPIRATION DATE FOR HEAD AND LINER. DOI: (B)(6) 2008; DOR: (B)(6) 2012; ( RIGHT HIP).

  Patient problems: Discomfort; Pain; Test Result; Tissue Damage

  MAUDE report 8394124 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, BURNING SENSATION, DIFFICULTY MOVING AROUND, TINGLING AND NUMBNESS, RINGING EARS, VISION PROBLEMS, BONE LOSS AND DECREASED MOBILITY, METALLOSIS, INJURY AND DISFIGUREMENT. CLINIC VISIT NOTES ALLEGES MYALGIA, NEUROPATHY AND LOW BACK PAIN. IT WAS ALSO ALLEGED THAT LAB RESULTS REVEALED ELEVATED LEVELS OF COBALT AND CHROMIUM IN THE BLOOD; NO VALUES PROVIDED.

  Patient problems: Deformity/ Disfigurement; Hypoesthesia; Injury; Limited Mobility Of The Implanted Joint; Neuropathy; Pain; Test Result; Tissue Damage

  MAUDE report 8235639 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, BURNING SENSATION, DIFFICULTY MOVING AROUND, TINGLING AND NUMBNESS, RINGING EARS, VISION PROBLEMS, BONE LOSS AND DECREASED MOBILITY, METALLOSIS, INJURY AND DISFIGUREMENT. CLINIC VISIT NOTES ALLEGES MYALGIA, NEUROPATHY AND LOW BACK PAIN. IT WAS ALSO ALLEGED THAT LAB RESULTS REVEALED ELEVATED LEVELS OF COBALT AND CHROMIUM IN THE BLOOD; NO VALUES PROVIDED.

  Patient problems: Deformity/ Disfigurement; Hypoesthesia; Injury; Limited Mobility Of The Implanted Joint; Neuropathy; Pain; Test Result; Tissue Damage

  MAUDE report 8235620 ↗
• InjuryJun 6, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE AND LOOSENING OF THE STEM COMPONENT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO STATED THAT THE PATIENT HAS EXTREMELY BRITTLE BONE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7572880 ↗