SUMMIT 1570-12-165Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295060208), received between Dec 14, 2017 and Oct 1, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 20 SEPT 2024. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED DUE TO FAILED INTERNAL PROSTHESIS OF THE LEFT HIP. OPERATIVE NOTES INDICATED PAIN, METALLOSIS, AND FOUND LARGE AREA OF OSTEOLYSIS ON POSTERIOR ASPECT OF THE FEMUR. DOI: (B)(6) 2009 DOR: (B)(6) 2024 LEFT HIP.

  Patient problems: Foreign Body Reaction; Osteolysis; Pain

  MAUDE report 20345686 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008; DOR: (B)(6) 2013; (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8499751 ↗
• InjuryNov 20, 2018Loss of Osseointegration; Loss of Osseointegration

  LITIGATION PAPERS ALLEGE SHORTLY AFTER SURGERY, PATIENT BEGAN EXPERIENCING PAIN AND TENDERNESS IN HIS LEFT HIP AND GROIN. IT IS ALSO ALLEGED THE PAIN AND TENDERNESS HAS NEVER GONE AWAY AND OFTEN IS SO UNBEARABLE THAT PATIENT CANNOT STAND OR WALK. UPDATE PPF ALLEGES LOOSENING OF CUP, LOOSENING OF STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. PPF ALSO ALLEGES PULMONARY EMBOLISM AFTER THE FIRST REVISION, HOWEVER, IT IS NOT SUGGESTED THAT DEPUY PRODUCTS WERE CONTRIBUTORY OR INVOLVED. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (LEFT HIP).

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

  MAUDE report 8089266 ↗
• InjuryMar 27, 2018Appropriate Device Problem Term/Code Not Available; Noise, Audible; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  LITIGATION ALLEGES THAT THE PATIENT IS REQUIRED TO LIVE WITH PAIN, CRUNCHING, LIMPING, POPPING, ELEVATED LEVELS OF METAL IONS IN HIS BLOOD AND CONTINUES TO REQUIRE ONGOING MEDICAL CARE FOR BOTH HIPS. DOI: (B)(6) 2007 RIGHT HIP DOR: NONE REPORTED. DOI: (B)(6) 2008 LEFT HIP DOR: NONE REPORTED. PATIENT IS BILATERAL. PATIENT IS A RESIDENT OF (B)(6). UPDATE - (B)(6) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THIS PC IS FOR THE LEFT HIP. SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Pain; Test Result

  MAUDE report 7374090 ↗
• InjuryFeb 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATES PATIENT FELL WHILE SKIING RESULTING IN A PERIPROSTHETIC FEMUR FRACTURE AROUND AND DISTAL TO SUMMIT STEM. SURGEON WAS ABLE TO EXPLANT THE SIZE 9HI SUMMIT STEM AND 36+1.5 CERAMIC REVISION FEMORAL HEAD WITHOUT ANY COMPLICATIONS OR BONE LOSS. SURGEON USED A STRYKER RESTORATION MODULAR STEM AND CABLES TO FIX THE PATIENTS FRACTURE. THE PINNACLE 58 CUB AND 58+4N LINER WAS WELL FIXED. IT WAS ALSO INDICATED THAT THE STEM WAS LOOSE DUE TO FRACTURE INVOLVING BONE AROUND FEMORAL STEM. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7240640 ↗
• InjuryDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). PATIENT WAS REVISED TO ADDRESS GROIN PAIN. THE SURGEON DIAGNOSED ALVAL. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (RIGHT SIDE). UPDATE 2/28/2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT HAD A TENDER LYMPNODE IN THE GROIN, PAIN, ELEVATED CHROMIUM AND COBALT AND SEEMS TO HAVE ASEPTIC LYMPHOCYTIC VASCULITIS ULCERATED LESIONS. REVISION NOTES REPORTED THAT THE PATIENT HAD PAIN AND ALVAL REACTION. IT WAS ALSO INDICATED THAT A LARGE AMOUNT OF BURSITIC FLUID HAS BEEN EVACUATED AND SEVERE ALVAL. DOI: (B)(6) 2008; DOR: (B)(6) 2011.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 7117335 ↗