SUMMIT 1570-02-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295059486), received between Jul 31, 2017 and May 8, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Biocompatibility” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO PERIPROSTHETIC FEMUR FRACTURE. AT REMOVAL THERE WAS MODERATE YELLOWING ON THE LINER.

  Patient problems: Limb Fracture

  MAUDE report 21986659 ↗
• InjuryOct 6, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD 20 SEP 2022. PATIENT WAS REVISED WAS DUE TO PAIN, TOXIC LEVELS OF COBALT AND CHROMIUM, MRI SHOWED CONSISTENT METALLOSIS. DOI: 2011, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 15551044 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION COMPLAINT RECEIVED AD 18 APR 2022. LITIGATION ALLEGES PAIN, SUFFERING AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2007. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 14247019 ↗
• InjuryJul 24, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE JOINT WAS INFECTED, COMPONENTS REMOVED AND PLACEMENT OF AN ANTIBIOTIC SPACER. STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE DUE TO INFECTION, CUP WAS WELL FIXED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10318404 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: MAY 19, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, WEAKNESS, SWELLING IN BOTH LEGS, GRINDING AND CLICKING UPON BENDING. PATIENT WAS ADVISED FOR REVISION WHEN PAIN IS PERSISTED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THERE ARE NO LABORATORY RESULTS OR EXAMINATION NOTES FOR THE ALLEGED SWELLING AND CLICKING. SHALL THERE BE ANY INFORMATION RECEIVED , THIS COMPLAINT WILL BE UPDATED. UPDATE AD 8 AUG 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: NONE REPORTED(LEFT HIP). PATIENT IS BILATERAL. SEE (B)(4) FOR RIGHT HIP.

  Patient problems: Pain; Swelling; Test Result; Weakness

  MAUDE report 8939830 ↗
• InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A PERIPROSTHETIC FRACTURE RIGHT PROXIMAL FEMUR 3CM BELOW CALCAR AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. NO OBVIOUS FALL OR INJURY REPORTED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8616066 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF CLAIM AND MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS METALLOSIS. THE OPERATIVE REPORT INDICATED SOME GRAY FLUID AND A TREMENDOUS AMOUNT OF SCAR TISSUE WITH SOME GRAY SYNOVITIS WHICH WAS THEN DEBRIDED. METAL DEBRIS WERE CLEANSED VIA PULSED LAVAGE IRRIGATION. ADDITIONALLY THE PATIENT WAS EXPERIENCING PAIN AND HAD EXCESSIVE METAL IONS IN HIS SERUM. THE ACETABULAR COMPONENT WAS NOTED TO BE VERY VERTICAL THUS A FISHING LINER TO CHANGE THE CENTER ROTATION WAS TRIALED. NO LAB RESULTS PROVIDED. (LEFT HIP).

  Patient problems: No Code Available; Pain; Scar Tissue; Test Result; Tissue Damage

  MAUDE report 8528247 ↗
• InjuryApr 18, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND WEAKNESS. UPDATE AD 30 AUG 2018 - RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGE FRACTURE (COMPONENT), METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Bone Fracture(s); Test Result; Tissue Damage

  MAUDE report 8528232 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT A PERIPROSTHETIC FEMUR FRACTURE WAS FOUND 30 DAYS POSTOPERATIVELY AND WAS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION. NO INFORMATION WAS PROVIDED TO CONFIRM IF ANY DEPUY PRODUCTS WERE REVISED. (LEFT HIP).

  Patient problems: No Code Available

  MAUDE report 8527815 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND PPF ALLEGES PAIN, LIMITED MOBILITY, METAL WEAR, METALLOSIS, ELEVATED METAL IONS AND LOOSENING OF CUP. AFTER REVIEW OF THE MEDICAL RECORDS NO ADDITIONAL INFORMATION TO BE ADDED. DOI: (B)(6) 2005; DOR: NON-REPORTED (RIGHT HIP). PATIENT IS BILATERAL.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Test Result; Tissue Damage

  MAUDE report 8455198 ↗
• InjuryMar 12, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005, DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; Osteolysis; Pain; Test Result

  MAUDE report 8411502 ↗
• InjuryFeb 15, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. PATIENT ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE AD 27 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. ADDED STEM DUE TO ELEVATED METAL IONS.

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

  MAUDE report 8342727 ↗
• InjurySep 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES ELEVATED IONS. DOI: (B)(6) 2004; DOR: (B)(6) 2012; (RIGHT HIP).

  Patient problems: Not Applicable; Pain; Test Result

  MAUDE report 7905793 ↗
• InjuryAug 27, 2018Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  ASR LITGATION RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, LITIGATION ALLEGES INJURY, PAIN, DISFIGUREMENT, AND EMOTIONAL DISTRESS.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Deformity/ Disfigurement; Depression; Distress; Emotional Changes; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Not Applicable; Pain; Physical Asymmetry; Test Result; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 7819223 ↗
• InjuryMay 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, DISCOMFORT, SORENESS, AND TINGLING IN THE AREA OF HIS HIP IMPLANT. ADDITIONALLY, METAL IONS AND PARTICLES HAVE BEEN RELEASED INTO PATIENT'S BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT WILL LIKELY NEED TO UNDERGO PREMATURE REVISION SURGERY. DOI: (B)(6) 2008 - DOR: NONE REPORTED; (RIGHT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 10/18/2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PATIENT DEMOGRAPHICS ADDED. UPDATE AD 25 APR 2018 - (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF RECORDS. THERE IS NO NEW ALLEGED INFORMATION. THE LAW FIRM NAME, MANUFACTURING DATE, UDI, AND PATIENT HARM HAS BEEN UPDATED AS WELL. IMPACTED PRODUCT RECORD FOR THE STEM (B)(4), HEAD ((B)(4), AND LINER (B)(4) WAS ADDED. DOI: (B)(6) 2008; DOR: NONE REPORTED; RIGHT HIP.

  Patient problems: Discomfort; No Code Available; Pain; Test Result

  MAUDE report 7544273 ↗
• InjuryFeb 15, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATED THAT PATIENT CAME BACK 1 WEEK POST OP WITH A MEDIAL CALCAR FRACTURE. THE SUMMIT STEM SUBSIDED CAUSING THE PATIENT TO DISLOCATE. THEY REMOVED THE STEM AND HEAD AND REPLACED WITH A RECALIM MODULAR STEM. THE CUP AND LINER APPEARED TO BE IN GOOD POSITIONING SO WE LEFT THOSE IN PLACE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNKNOWN SIDE. NO SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7272752 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAS BEEN HAVING PAIN. SURGEON ORDERED AN ION LEVEL TEST SUSPECTING TRUNIONOSIS. THE COBALT SERUM LEVEL WAS 8.8 UG/L WHEN TESTED ON (B)(6) 2017. THERE WAS NOTED DARKENING OF THE SYNOVIAL TISSUE. THERE WAS ALSO SOME NOTED BLACK SUBSTANCE INSIDE THE HEAD. THE HEAD WAS NOT IN THE POSSESSION, BUT HOSPITAL POLICY IS THAT THE IMPLANT HAD TO BE CLEANED AND STERILIZED. IT WAS NOT LOOSE ON THE TAPER. SURGEON ELECTED TO KEEP THE STEM IN PLACE AND UTILIZED A CERAMIC HEAD. HE EXAMINED IT CLOSE AND FELT LIKE THERE WAS LITTLE TO NO WEAR. DOI: (B)(6) 2011; DOR: (B)(6) 2018 RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7224180 ↗
• InjuryAug 1, 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

  PPF ALLEGES METAL WEAR AND METALLOSIS.

  Patient problems: Host-Tissue Reaction; Joint Dislocation; Osteolysis; Pain

  MAUDE report 6758027 ↗
• InjuryJul 31, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES METAL WEAR. UPDATED CODE FOR METALLOSIS AND BLOOD HEAVY METAL.

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

  MAUDE report 6754977 ↗