SUMMIT 1570-06-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295059752), received between May 22, 2018 and Jul 22, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE HEMI CONVERSION TO A TOTAL HIP ARTHOPLASTY. CEMENTED SUMMIT STEM BECAME LOOSE AND WAS REPLACED WITH RECLAIM MONOBLOC. THE LOOSENING INTERFACE WAS CEMENT TO IMPLANT. THE CEMENT MANUFACTURER WAS DEPUY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Insufficient Information

  MAUDE report 22564625 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT FOR INFECTION AND RE IMPLANT A TEMPORARY SPACER. LEFT HIP. ORIGINAL DATE OF SURGERY (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20369818 ↗
• InjuryMar 15, 2021Migration; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT FELT PAIN AT FEMUR IN 2021. THE PATIENT WAS REVISED DUE TO SUBSIDENCE AND THE INVERSION OF THE STEM BY X-RAYS. IN THE REVISION SURGERY, THE SURGEON REMOVED THE CUP AND THE STEM WITHOUT ANY PROBLEM, BUT HE HAD DIFFICULTY IN REMOVING CEMENT AND THE CEMENT RESTRICTOR WHICH HE MANAGED TO REMOVE EVENTUALLY. THERE WAS NO DELAY IN THE REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014. DOR: (B)(6) 2021; UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 11485985 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA BHA. IT WAS REPORTED THAT DURING THE SURGERY, 6 MINUTES AFTER THE INJECTION OF THE CEMENT TO THE PATIENT'S FEMUR AND IMPLANTING THE STEM, HER BLOOD PRESSURE DROPPED PRECIPITOUSLY. THE CEMENT CURED IN 11 MINUTES, THE SURGEON IMPLANTED ALL IMPLANTS WHILE ADMINISTERING MEDICATION. THEN, THE SURGEON PUT THE PATIENT IN THE SUPINE POSITION, THE PATIENT WENT INTO CARDIAC ARREST. THE ANESTHESIOLOGIST AND NURSE PERFORMED THE PROCEDURE AND RESUSCITATED THE PATIENT, THE SURGEON CLOSED INCISION WITH STABLE STATE OF THE PATIENT. THE SURGERY WAS COMPLETED WITH 40 MINUTES DELAY. THE SURGEON COMMENTED THAT IT WAS UNKNOWN IF IT WAS CAUSED BY THROMBUS OR THE CEMENT UNTIL EXAM. THE SURGEON WILL CHECK BY CT SCAN AFTER THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest; No Code Available; Not Applicable

  MAUDE report 10835955 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES COMPARTMENT SYNDROME AND WALKING DIFFICULTY. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED INFECTED LEFT TOTAL HIP ARTHROPLASTY. PROCEDURE NOTES INDICATED ALL GRAM STAINS AS WELL AS CELL COUNTS PER HIGH POWER FIELD WERE ACCEPTABLE LIMITS SHOWING NO EVIDENCE OF INFECTION. FURTHER DISSECTION WAS PERFORMED DOWN THE FEMUR SHOW EVIDENCE OF SIGNIFICANT BONE LOSS. AFTER THOROUGH INSPECTION THERE WAS A SIGNIFICANT MEDIAL BONY DEFICIT OF APPROXIMATELY 8 CM. DOI: (B)(6) 2011; DOR: (B)(6) 2011; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Injury; No Code Available; Unspecified Infection

  MAUDE report 9187121 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2011 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8478077 ↗
• InjuryNov 16, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE HIP STEM WAS LOOSE.

  Patient problems: Not Applicable

  MAUDE report 8078004 ↗
• InjuryOct 8, 2018Fracture; Fracture

  IT WAS DISCOVERED THE PATIENT EXPERIENCED A TROCHANTER FRACTURE DURING THE PRIMARY OPERATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 7944471 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES OF INFECTION AFTER FIRST REVISION. NO REVISION OPERATIVE NOTE HAS BEEN PROVIDED. THERE WAS NO LABORATORY RESULT FOR THE ALLEGED INFECTION. FIRST REVISION WAS CAPTURED UNDER (B)(4). DOI: (B)(6) 2010 - DOR: (B)(6) 2010 (RIGHT HIP) SECOND REVISION. (B)(4)-FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 7768215 ↗
• InjuryMay 22, 2018Difficult to Insert; Difficult to Insert

  DER STATES THAT THE STEM DID NOT SEAT IN THE CEMENT MANTLE, WE PULLED IT OUT BY HAND AFTER THE CEMENT CURED, THE STEM WAS HANDLED CORRECTLY BY THE SURGICAL TEAM. CEMENT WAS REMOVED AND A NEW STEM WAS INSERTED. DOE: (B)(6) 2018. RIGHT HIP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7533068 ↗