SUMMIT 1570-03-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295059523), received between Dec 14, 2018 and Jan 7, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMORAL STEM AND HEAD WERE REVISED DUE TO FEMORAL FRACTURE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23993079 ↗
• InjuryOct 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE IMPLANTS WERE REVISED DUE TO STEM LOOSENING. FEMORAL STEM WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. AFFECTED SIDE: LEFT HIP

  Patient problems: Insufficient Information

  MAUDE report 23356908 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE A CONVERSION WAS HELD TO CONVERT A HEMI TO A TOTAL HIP DUE TO THE PATIENT COMPLAINING OF ACETABULUM PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19190668 ↗
• InjuryFeb 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM, THIGH PAIN. DONE ELSE WHERE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 18685515 ↗
• MalfunctionSep 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACHED SIZE 2 SUMMIT CEMENTED AND WHEN THEY IMPLANTED THE FINAL STEM IN THE FEMORAL CANAL AFTER PUTTING CEMENT, THE STEM DID NOT WANT TO GO DOWN AS THE BROACH. THEY REMOVED THE FINALE IMPLANT BEFORE THE CEMENT GOT HARDEN AND REMOVED THE EXCESS OF CEMENT. SURGERY WAS DELAYED 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816345 ↗
• InjuryJul 31, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AT AN UNKNOWN INTERFACE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17423717 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS EXPLANTATION OF AN ANTIBIOTIC SPACER THAT HAD DEVELOPED A PERI-PROSTHETIC FRACTURE. RE-IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 15605075 ↗
• InjurySep 22, 2021Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. PATIENT HAD AN ALVAL ON THE SIDE OF HER HIP LEADING THE SURGEON TO BELIEVE THAT THE HIP PROSTHESIS WAS HAVING MICROMOTION CAUSING SOME METAL WEAR. ORIGINALLY IMPLANTS WERE A COBALT CHROME SUMMIT CEMENTED STEM WITH A COBALT CHROME SPACER AND MONOPOLAR HEMI ARTHROPLASTY HEAD. SHE WAS REVISED TO A TOTAL HIP WITH A PINNACLE CUP, ALTRX LINER, SCREW, CORAIL REVISION, AND DELTA CERAMIC HEAD. LACK OF METALOSYS IN JOINT BUT RAISED ION LEVELS PRE OP. DOI: (B)(6) 2018, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction

  MAUDE report 12513534 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS AN INFECTION OF UNKNOWN ETIOLOGY. ALL COMPONENTS WERE EXPLANTED FOR A 2 STAGE REVISION. THE ACETABULAR COMPONENTS WERE COMPETITOR. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP

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

  MAUDE report 12122573 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE UNF AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO SYMPTOMATIC METALLOSIS, PSEUDOTUMOR, ALVAL, ELEVATED METAL IONS, CRP AND SEDIMENTATION RATE RESULTING TO PAIN, BONE NECROSIS OF THE PROXIMAL FEMUR, LARGE LYTIC LESION OF THE ISCHIUM, LIMP AND LEG LENGTH DIFFERENCE. OPERATIVE NOTE REPORTED PSEUDOTUMOR FLUID COLLECTION APPROX. 15 CC OF RED SEROSANGUINOUS FLUID. THERE IS SIGNIFICANT PSEUDO-CAPSULAR EXPANSION AND GRADE TINTED STAINED TISSUE CONSISTENT WITH METAL DEBRIS AND DAMAGE. CUP LOOKS VERTICAL AND ANTEVERTED RELATED TO SPINAL PELVIC IMBALANCE. COMPROMISE OF THE ABDUCTORS BY THE NECROSIS OF THE TROCHANTER FROM THE METALLOSIS DAMAGE. PATHOLOGY REPORT COMPONENT HAD THICK FIBROSIS AND SYNOVIAL LINING ERODED. MODERATE GRADE FOR ALVAL. LAB RESULT FOR CHROMIUM AND COBALT SHOWS ABOVE 7 PPB. DOI: 2009: DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Physical Asymmetry; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 11349550 ↗
• InjuryJan 27, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED AS REVISION OF CEMENTED BIPOLAR DUE TO PERI-PROSTHETIC FRACTURE DUE TO PT FALL. REVISED TO A RECLAIM BIPOLAR CONSTRUCT. B2 FRACTURE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11236962 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GROSSLY INFECTED. ALL IMPLANTS WERE REMOVED. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS FROM COMPETITOR'S. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8730549 ↗
• InjuryMay 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE FEMORAL CEMENT MANTLE FAILED. THE LOOSENING WAS AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. COMPETITOR'S CEMENT WAS USED.

  Patient problems: No Code Available

  MAUDE report 8603502 ↗
• InjuryFeb 4, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS FAILURE OF THE LEFT HIP PROSTHESIS DUE TO ASEPTIC LOOSENING AT CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 8301032 ↗
• InjuryDec 14, 2018Failure to Osseointegrate; Failure to Osseointegrate

  ALLEGED LOOSENING OF CUP AND STEM, FRACTURE (BONE) AND INFECTION.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8164631 ↗