SUMMIT 1570-06-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295059776), received between Dec 28, 2017 and Nov 13, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23544301 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INSTABILITY. HIS SURGICALLY REPAIRED BIPOLAR HIP HAD DISLOCATED THREE TIME SINCE HIS FEMORAL NECK FRACTURE REPAIR THREE WEEKS EARLIER. DURING THE REVISION PROCEDURE, THE PATIENT'S BIPOLAR HEAD AND CEMENTED STEM WERE REMOVED AND HIS HIP WAS CONVERTED TO A GIRDLESTONE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17169726 ↗
• InjuryJul 8, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A CONVERSION FROM A HEMI HIP TO A TOTAL HIP ARTHROPLASTY. THE STEM WAS ALSO FOUND TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE, POSSIBLY FROM THE FORCE REQUIRED TO DISSOCIATE THE UNIPOLAR HEAD AND SLEEVE FROM THE FEMORAL TRUNION. THE SUMMIT BASIC CEMENTED STEM AND RESIDUAL CEMENT WERE REMOVED FROM THE FEMORAL CANAL IN PREPARATION FOR THE RECLAIM FEMORAL STEM. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14956391 ↗
• InjurySep 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT A REMOVAL OF A LOOSE CEMENTED FEMORAL COMPONENT AND A SUBSEQUENT CONVERSION OF A HEMI HIP ARTHROPLASTY TO A TOTAL HIP WERE DONE THE LOOSENING INTERFACE WAS AT CEMENT TO IMPLANT. DOI: (B)(6) 2016. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12432221 ↗
• InjuryJun 8, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE STEM BECAME LOOSE WHEN SURGEON WAS ATTEMPTING TO REMOVE HEAD. DOI: (B)(6) 2021 - DOI: (B)(6) 2021 (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11957423 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10130375 ↗
• InjuryJun 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A TOTAL HIP. IT WAS ALSO INDICATED THAT THE STEM WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 10114030 ↗
• InjuryDec 5, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS LOOSENING AT UNKNOWN INTERFACE AND PAIN. NO DELAY IN SURGERY. NO INJURY TO PATIENT. REMOVED OLD SUMMIT STEM, ARTICULEZE HEAD, CEMENTRALIZER, CEMENT RESTRICTOR, CEMENT MANTLE AND NEUTRAL LINER. IMPLANT A RECLAIM STEM, SZ 18X140 WITH 20X85 BODY AND 32X52 +4 NEUTRAL CONTRAIL LINER AND NEW 32+ 1.5 ARTICULEZE HEAD. DOI: (B)(6) 2017. DOR: (B)(6) 2019. LEFT HIP. .

  Patient problems: No Code Available; Pain

  MAUDE report 9419371 ↗
• MalfunctionSep 13, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS A TINY HOLE WAS DISCOVERED ON THE OUTER UNSTERILE PACKAGING OF A CEMENTED SUMMIT STEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9026523 ↗
• InjuryAug 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF SUMMIT CEMENTED STEM AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON EXTRACTED STEM AND BIPOLAR SHELL REVISING WITH PINNACLE/SROM. DOI: UNKNOWN; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8888946 ↗
• InjuryAug 12, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SUMMIT STEM SUBSIDED DUE TO FALL. REVISED WITH SROM. DOI: UNKNOWN; DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 8885137 ↗
• InjuryJul 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HEMI HIP. IT WAS ALSO INDICATED THAT THE CEMENTED STEM WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. HE CONVERTED TO A TOTAL HIP. LOT NUMBERS WERE NOT TOTALLY VISIBLE. WE COULD ONLY MAKE OUT A LOT NUMBER ON THE STEM. DOI: (B)(6) 2013; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8792941 ↗
• InjuryMay 9, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT BECOME INFECTED AND ALL IMPLANTS WERE REMOVED. I & D WAS PERFORMED AND NEW PROSTALAC IMPLANTS IMPLANTED. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING OF THE STEM AT IMPLANT TO CEMENT INTERFACE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 8594762 ↗
• InjuryApr 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT MANUFACTURER WAS USED. THE JOINT WAS WASHED OUT. THE ENDO HEAD AND NECK WERE REMOVED. THE SAME STEM WAS RECEMENTED AND A NEW HEAD AND NECK WERE USED. ANTIBIOTIC BEADS WERE PLACED, THE STEM RETAINED WAS PART #157006100/D17101164. DOI: (B)(6) 2018. DOR: (B)(6) 2018: RIGHT HIP.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 7424728 ↗
• InjuryDec 28, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. HE WAS BROUGHT TO SURGERY FOR AN I&D WASH OUT AND UNI POLAR HEAD EXCHANGE. DURING SURGERY, IT WAS DISCOVERED THAT THE CEMENTED STEM WAS LOOSE AND HAD A BIOFILM, MUCUS TYPE FILM AROUND IT AND NEEDED TO BE REMOVED. A NEW SMALLER STEM AND UNI HEAD WERE THEN IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2017. UNKNOWN AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7150596 ↗