SUMMIT 1570-12-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295060192), received between Jan 13, 2017 and Jun 25, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: AFFECTED SIDE WAS RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 22328576 ↗
• InjuryJun 2, 2022Degraded; Degraded

  PLAINTIFF PRELIMINARY DISCLOSURE AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS DISLOCATED ACETABULAR COMPONENT. PATIENT ALLEGES PAIN AND HAS DEGENERATIVE DISEASE OF THE LUMBAR SPINE. X-RAYS WAS OBTAINED AND NOTED THAT THERE IS A COMPLETE DISLODGEMENT/DISLOCATION OF THE ACETABULAR CUP WITH APPROXIMATELY 180 DEGREES OF ROTATION OF THE CUP WITHIN THE NATIVE BONY ACETABULUM. THE POSTERIOR PSEUDOCAPSULE WERE ELEVATED FROM THE POSTERIOR ASPECT. THERE WAS SIGNIFICANT AMOUNT OF SEROSANGUINEOUS FLUID THAT DID NOT APPEAR PURULENT. THERE WAS MINIMAL EVIDENCE OF ANY BONY INGROWTH ON THE POROUS SURFACE OF THE CUP. THERE WAS OSTEOLYSIS AT THE POSTERIOR FEMUR WHICH WAS CURETTED OF FIBROUS DEBRIS. THE TRUNION SHOWED MINIMAL EVIDENCE OF CORROSION. DOI: (B)(6) 2008. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: Foreign Body Reaction; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 14572956 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. PC WAS CREATED TO CAPTURE FOR RIGHT HIP. INCREASED METAL IONS. DOI: (B)(6) 2008 DOR: UNK RIGHT HIP. PLEASE SEE (B)(4) FOR LEFT HIP 1ST REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12923367 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS A PSEUDOTUMOR. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, PSEUDOTUMOR AND OSTEOLYSIS. REVISION NOTES REPORTED EROSION OF PROXIMAL FEMUR, EXTENSIVE OSTEOLYSIS, METALLOSIS, VERY VERTICAL ACETABULAR COMPONENT, LARGE TISSUE MASS PSEUDOTUMOR FORMATION, EXTENSIVE OSTEONECROSIS, AND CYST ON THE POSTERIOR WALL. LAB DATA SHOWS COBALT ION LEVEL IS ABOVE 7 PPB. DOI: (B)(6) 2005. DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Erosion; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9915665 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECEIVED. LITIGATION ALLEGES PAIN AND SUFFERING. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES FRACTURE (BONE) AND ELEVATED METAL IONS. DOI: (B)(6) 2009, DOR: (B)(6) 2016, (RIGHT HIP) FIRST REVISION.

  Patient problems: Pain; Test Result

  MAUDE report 9007788 ↗
• InjuryMay 28, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD A FALL.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration; No Code Available; Tissue Damage

  MAUDE report 8645654 ↗
• InjuryApr 10, 2019Fracture; Biocompatibility; Fracture; Biocompatibility

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE, PAIN, DISCOMFORT, IMMOBILITY AND INFLAMMATION. UPDATE REC¿D 4/30/2014¿ PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON : 5/29/2014. UPDATE RECEIVED 05/13/2016 THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION OR INVESTIGATION. COMPLAINT WAS UPDATED ON 05/19/2016. UPDATE AD 31 JUL 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 METALLOSIS, COMPONENT FRACTURE AND INFECTION. ADDED ALL OTHER IMPLANTS DUE TO ALLEGED INFECTION. ACCOUNT NAME, FACILITY NAME, PATIENT CODE, PRODUCTS EXPIRATION AND UDI WERE ALSO ADDED. CORRECTED EVENT DATE. DOI: (B)(6) 2008- DOR: (B)(6) 2016 (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Limited Mobility Of The Implanted Joint; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8498965 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF RECEIVED. PPF ALLEGED ELEVATED METAL IONS. THE METAL LINER, METAL HEAD, AND THE STEM WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATION. DOI: (B)(6) 2009; DOR: (B)(6) 2015; (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8416557 ↗
• InjuryJan 29, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM CHRONIC AND SEVERE PAIN AND DIFFICULTY WALKING. UPDATE AD 12 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Pain; Test Result

  MAUDE report 8284469 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8258288 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2012 (RIGHT HIP).

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

  MAUDE report 8189302 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION PAPERS ALLEGE THE PATIENT BEGAN EXPERIENCING PAIN AND TENDERNESS IN HER RIGHT HIP AND GROIN. ADDITIONALLY IT IS ALLEGED THE PATIENT HAS SUFFERED FROM SEVERE PAIN, NUMBNESS, INABILITY TO SLEEP NORMALLY, AND FACES POSSIBLE METAL POISONING, BONE LOSS, CHRONIC PAIN, A DECREASE IN HIS QUALITY OF LIFE AND OTHER SERIOUS MEDICAL PROBLEMS. UPDATE: (B)(6) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. DOI: (B)(6) 2005, DOR: NONE REPORTED, (RIGHT HIP). DOI:(B)(6) 2005, DOR: NON REPORTED, (LEFT HIP).

  Patient problems: Discomfort; Hypoesthesia; Pain; Test Result

  MAUDE report 7628648 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ALLEGES PAIN AND WEAKNESS, INABILITY TO WALK AND MOVE, METALLOSIS, ELEVATED METAL IONS LEVELS, ANXIETY, FEAR, MENTAL ANGUISH AND EMOTIONAL AND PHYSICAL DAMAGES. DOI: (B)(6) 2007; DOR: NOT REPORTED: LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Confusion/ Disorientation; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Metal Related Pathology; No Code Available; Pain; Tissue Damage; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Weakness

  MAUDE report 7406303 ↗
• InjurySep 15, 2017Corroded; Degraded; Corroded; Degraded

  AUG 17, 2017: LEGAL MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES FATIGUE, PAIN, CLICKING SENSATION, LIMITED MOBILITY, HIGH COBALT LEVELS, INFECTION, AND PATHOLOGY REPORTS CONFIRMED PRESENCE OF PROPIONIBACTERIUM ACNES. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISION NOTES REPORTED NECROSIS, PURULENT APPEARING FLUID, SYNOVIAL TYPE LINING AND GRANULATION TISSUE WHICH APPEARS VERY THICKENED, REDDENED AND ABNORMAL, SMALL AMOUNT OF RESIDUAL CORROSION ON THE TAPER, LARGE LYTIC DEFECT. PATHOLOGIST DESCRIBES INCREASED ACUTE INFLAMMATION ALL CONSISTENT WITH INFECTION. MRI SHOWS HYPERINTENSE OSTEOLYSIS. LABORATORY RESULTS FOR COBALT-CHROMIUM SHOWED BELOW 7PPB. PART AND LOT INFORMATION FOR HEAD AND LINER WERE PROVIDED BUT NOT READABLE.

  Patient problems: Adhesion(s); Fatigue; Impaired Healing; Inflammation; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Necrosis; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 6869291 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS ALSO REPORTED THAT THE PATIENT HAD HIP FRACTURE IN MAY OF THIS YEAR AND NOW SUFFERING A TERRIBLE INFECTED RIGHT HIP JOINT. THE SURGEON REMOVED ALL DEPUY COMPONENTS, REAMED THE FEMORAL CANAL, IRRIGATED THE WOUND WITH COPIOUS AMOUNTS OF ANTIBIOTIC SALINE SOLUTION AND IMPLANTED APPROXIMATELY 12 CC OF ANTIBIOTIC BEADS.

  Patient problems: Bone Fracture(s); Pain; Unspecified Infection

  MAUDE report 6804116 ↗
• InjuryJan 13, 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

  PATIENT WAS REVISED TO REMOVE METAL LINER AND HEAD. UPDATE REC¿D 12/19/2016 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND GENERAL LITIGATION NOTES METAL ON METAL IMPLICATIONS. ADDING THE STEM TO THE COMPLAINT FOR THE ELEVATED IONS.

  Patient problems: Discomfort; Host-Tissue Reaction; Irritation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Skin Irritation

  MAUDE report 6248791 ↗