SUMMIT 1570-02-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295059493), received between Nov 4, 2014 and Jun 1, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED MECHANICAL FAILURE OF PROSTHETIC JOINT, PAINFUL RIGHT TOTAL HIP ARTHROPLASTY WITH ELEVATED METAL IONS COBALT. OPERATIVE NOTES REPORTED, THE PATIENT HAD A LARGE FLUID COLLECTION THROUGHOUT HIS RIGHT HIP JOINT AND A LARGE SOFT TISSUE LESION CONSISTENT WITH METAL DEBRIS. DOI: (B)(6) 2004; DOR: (B)(6) 2020; (RIGHT HIP).

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

  MAUDE report 11913884 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS AND PAIN. REVISION NOTES REPORTED EXTENSIVE METALLOSIS AND SOFT TISSUE DESTRUCTION, AND STAINING OF ENTIRE CAPSULE WITH METAL DEBRIS. DOI: (B)(6) 2009; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 9827716 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL, RESULTING IN A PERIPROSTHETIC FRACTURE. 58 SECTOR CUP DID NOT COME OUT. 6.5 X 20MM SCREW DID NOT COME OUT. DOI: (B)(6) 2013; DOR: (B)(6) 2020; LEFT SIDE.

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

  MAUDE report 9636633 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE REC¿D 05/11/2016 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALSO ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. COMPLAINT UPDATED 05/27/2016. UPDATE AD 5 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS, METAL WEAR AND METALLOSIS. ADDED STEM DUE TO ALLEGED HIGH METAL IONS. ACCOUNT NAME, FACILITY NAME, PATIENT HARMS AND PRODUCT DETAILS OF LINER, LOT NUMBER, MANUFACTURING DATE AND EXPIRATION OF HEAD WERE ALSO ADDED. CORRECTED PATIENT IDENTIFIER. DOI: (B)(6) 2005. DOR: (B)(6) 2015. (LEFT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; No Code Available; Pain; Test Result

  MAUDE report 9071532 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND DIFFICULTY AMBULATING. UPDATE AD 5 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 8992846 ↗
• InjuryMay 3, 2019Corroded; Corroded

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL METAL ON METAL TOTAL HIP ARTHROPLASTY. FINDINGS INCLUDE A SMALL PSEUDOTUMOR IN THE ANTERIOR ASPECT OF THE ACETABULUM TOWARDS PELVIS. THE STEM WAS CLEANED OF ANY EVIDENCE OF BLACK CORROSIVE MATERIAL.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8577800 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SWELLING, SORENESS, DIFFICULTY WALKING, DECREASED MOBILITY AND/OR THE NEED FOR REVISION SURGERY SINCE IMPLANTATION OF THE DEVICES. DOI: (B)(6) 2006 - DOR: NONE REPORTED (RIGHT HIP). PATIENT IS RESIDENT OF (B)(6). UPDATE AD 17 JAN 2019 RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF HAD NO ALLEGATION. ADDED LAW FIRM, PATIENT IDENTIFIER, AGE, PRODUCT DETAILS AND IMPACTED PRODUCTS (CUP, LINER, HEAD, STEM) SINCE LEGACY REPORTED ONLY ONE UNKNOWN DEPUY PINNACLE HIP. DOI: (B)(6) 2006 - DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 8300886 ↗
• InjuryJan 2, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 8207811 ↗
• InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7872317 ↗
• 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 1/17/13 - 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 RIGHT HIP. SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Pain; Test Result

  MAUDE report 7373605 ↗
• InjuryFeb 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION RECORD OF PINNACLE IMPLANT RECEIVED. LITIGATION ALLEGES PAIN, DECREASED RANGE OF MOTION WITH POSITIVE TRENDELENBURG SIGNS, DISTENDED ILIOPSOAS BURSA WITH COMPLEX FLUID, SUSPICIOUS FOR ADVERSE METAL REACTION AND METALLOSIS. DOI: (B)(6) 2009-DOR: (B)(6) 2017(LEFT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Host-Tissue Reaction; Loss of Range of Motion; Not Applicable; Pain; Test Result; Weakness

  MAUDE report 7243460 ↗
• InjuryJul 31, 2017Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN. UPDATE JUL 05, 2017: MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES KIDNEY FAILURE AFTER IMPLANT, DISLOCATION AND UNABLE TO WALK WITHOUT SUPPORT. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS METALLOSIS. REVISION NOTES NOTED SOME GRAY METALLOSIS OF THE GREATER TROCHANTER SOFT TISSUES. MRI SHOWED A FLUID COLLECTIONS BILATERALLY AND HE WAS NOTED TO HAVE EXTREMELY ELEVATED COBALT AND CHROMIUM LEVELS. IT WAS ALSO REPORTED IN THE MEDICAL RECORDS THAT SUBSEQUENT TO HIS METAL-ON-METAL HIPS, PATIENT ENDED UP WITH RENAL FAILURE AND ON DIALYSIS. LABORATORY RESULT FOR COBALT WAS ABOVE 7PPB. STEM HAS BEEN ADDED. PRODUCT CODES AND LOT NUMBERS WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON JUL 18, 2017. INVESTIGATION METHOD: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. THE REPORTED EVENT IS CONSIDERED ONE OF THE POSSIBLE COMPLICATIONS OF JOINT REPLACEMENT. THE COMPLAINT INF

  Patient problems: Foreign Body Reaction; Joint Dislocation; No Code Available; Pain; Tissue Damage

  MAUDE report 6755085 ↗
• InjuryNov 4, 2014Degraded; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  UPDATE REC'D 11/03/2014 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. PART/LOT WAS IDENTIFIED FROM PATIENT STICKER SHEET FOR SECOND HEAD. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 12/01/2014.

  Patient problems: Fluid Discharge; Foreign Body Reaction; Metal Related Pathology; Necrosis; No Code Available; Pain; Test Result; Unspecified Tissue Injury

  MAUDE report 4225528 ↗