SUMMIT POROCOAT 1570-11-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295060093), received between Dec 9, 2015 and Dec 10, 2025 — classified as 60 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONICAL INFECTION. SURGEON REMOVED IMPLANTS AND DID PLACEMENT OF A TEMPORARY SPACER UNTIL HEALING. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23773692 ↗
• InjuryJul 23, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF STEM AT BONE TO IMPLANT INTERFACE. THERE WERE NO COMPLICATIONS. DOI: (B)(6) 2007. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 22575638 ↗
• InjuryApr 10, 2024Degraded; Degraded

  ASR LITIGATION COMPLAINT RECEIVED AD 14 MAR 2024. PATIENT UNDERWENT SURGERY WITH NO REASON FOR REVISION. ADDITIONAL EVENT INFORMATION: UPDATE AD 4 APR 2024 PLAINTIFF DISCLOSURE FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES INDICATED INCREASING PAIN, COBALT AND CHROMIUM LEVEL SLOWLY RISE, MRI SCAN SHOWS LARGE AMOUNT OF SYNOVITIS. UPON INCISION A LARGE AMOUNT OF FLUID WAS ENCOUNTERED, THERE WAS SOME CORROSION AT THE BASE OF THE MORSE TAPER, BUT WAS ABLE TO REMOVE THIS WITHOUT DIFFICULTY. ATTENTION WAS PAID TO THE ACETABULUM AT THIS TIME, A LARGE AMOUNT OF SYNOVITIS WAS REMOVED. AGAIN, NO EVIDENCE OF INFECTION, BUT CERTAINLY METALOSIS WAS SEEN. DOI: (B)(6) 2007. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19084780 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EZTEC LEG LENGTH GUIDE WAS USED DURING THE CASE TO MEASURE THE PATIENTS LEG LENGTH PRIOR TO DISLOCATING THE HIP AND USED AS A GUIDE TO MAKE SURE IT WAS REPRODUCED. THE GUIDE ITSELF WAS STUCK WHEN TRYING TO MANEUVER THE PIECES TO ALLOW IT TO LOCK INTO PLACE ONCE MEASUREMENT WAS TAKEN. AS IT GOT STUCK, THE SURGEON WAS UNABLE TO USE IT FOR THE REMAINDER OF THE CASE TO CONFIRM IT HE REPRODUCED THE RIGHT LENGTH AND OFFSET SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639008 ↗
• InjuryAug 4, 2023Degraded; Degraded

  LITIGATION PAPERS ALLEGE PAIN, INJURY, AND ELEVATED METAL ION LEVELS. UPDATE REC¿D (B)(6) 2015 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. PART/LOT INFORMATION WAS IDENTIFIED FROM PATIENT STICKER SHEET. 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: (B)(6) 2015. LITIGATION COMPLAINT RECEIVED AD (B)(6) 2023. UPDATE AD (B)(6) 2023 LITIGATION RECORDS RECEIVED. LITIGATION RECORDS ALLEGES EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT AND ECONOMIC DAMAGES. ADDED ACCOUNT NAME, ASSOCIATED CONTACTS, CONCOMITANT PRODUCTS AND DOR. CORRECTED PATIENT INITIALS AND DOI. DOI: (B)(6) 2008. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Distress; Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain; Physical Asymmetry; Unspecified Tissue Injury

  MAUDE report 17458048 ↗
• MalfunctionFeb 13, 2023Migration; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FEMORAL FRACTURE; MILD TROCH FX WITH MIGRATION OF 5-6MM. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. AFFECTED SIDE: LEFT HIP. TREATMENT: ORAL MEDICATION (HYDROCODONE).

  Patient problems: Limb Fracture

  MAUDE report 16364116 ↗
• InjuryNov 21, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RECOVERING FOLLOWING REMOVAL OF DEPUY PINNACLE HIP DUE TO COMPLICATIONS INCLUDING PSEUDOTUMOR. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Cyst(s); Discomfort; Fall; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 15834000 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD ALLEGES THAT ON (B)(6) 2021, PATIENT HAD SEVERE METAL REACTION, PAIN, LOSS OF MOBILITY, METAL WEAR AND TOXIC HEAVY METAL POISONING AND AT REVISION PATIENT HAD SWELLING HIP AND FOUND A LARGE PSEUDOTUMOR, EXTENSIVE LYSIS AND MUSCULAR NECROSIS AND DEBRIS REMOVED. DOI: (B)(6) 2009.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15462566 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. PATIENT ALLEGES ELEVATED METAL ION, PAIN, INJURY, AND SUFFERING. DOI: (B)(6) 2007. DOR: (B)(6) 2021. AFFECTED SIDE: (LEFT HIP).

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

  MAUDE report 14247043 ↗
• InjuryMar 15, 2022Use of Device Problem; Use of Device Problem

  MEDICAL RECORD RECEIVED. PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT MALPOSITION AND MULTIPLE DISLOCATIONS. THERE WAS GROSSLY MALPOSITIONED ACETABULAR COMPONENT THAT HAS BECOME WELL FIXATED TO BONE WITH SUPERIOR ACETABULAR WALL LOSS AND POSTEROLATERAL WALL INSUFFICIENCY. DOI: (B)(6) 2010 - DOR: (B)(6) 2010 ( LEFT HIP).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13770074 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. THE PATIENT WAS IMPLANTED WITH ASR XL. IT WAS ALSO REPORTED THAT THE PATIENT HAD A REVISION SURGERY HOWEVER THERE WERE NO REASON OR REVISION NOTES PROVIDED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO MECHANICAL COMPLICATIONS OF METAL ON METAL HIP REPLACEMENT. PRIOR TO REVISION PATIENT ALLEGED PAIN, ELEVATED COBALT AND CHROMIUM LEVELS. THERE WAS SOME METALLOSIS ALONG THE TRUNNION. DOI: (B)(6) 2007; DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 12120646 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH A PROXIMAL FEMUR FRACTURE. AN 8HI SUMMIT STEM, 36-62 +4 10 DEGREE AND A METAL 36 +8.5 H. CUP WAS STABLE. THE SURGEON REMOVED IMPLANTS AND PUT A PINNACLE DUAL MOBILITY LINER 62/53 AND A 53/28 BIMENTUM LINER IN. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 12033210 ↗
• InjuryMar 31, 2021Migration; Migration

  ON (B)(6) 2019, THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY, TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO ASEPTIC LOOSE FEMORAL STEM. THE POST-OPERATIVE DIAGNOSIS WAS WELL-FIXED FEMORAL STEM. THE INDICATIONS FOR SURGERY INCLUDED: PAIN, LIMITED ABILITY TO WALK AND EXERCISE. PREOPERATIVE RADIOGRAPHS WERE REPORTED TO SHOW SUBSIDENCE OF THE STEM. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE STEM HAS SUBSIDED SLIGHTLY, BUT WAS WELL-FIXED. THE ACETABULAR CUP WAS NOTED TO BE WELL-FIXED AND THERE WAS NO EVIDENCE OF ANY ADVERSE REACTION TO WEAR DEBRIS. THE STEM AND THE ACETABULAR CUP WERE NOT REVISED. THE ACETABULAR LINER AND HEAD WERE REVISED. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT HIP).

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11594809 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PSF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED RIGHT METAL ON METAL TOTAL HIP ARTHROPLASTY WITH PSEUDOTUMOR AND OSTEOLYSIS OF PROXIMAL FEMUR. OPERATIVE NOTES INDICATED PAIN, DISCOMFORT, WALKING DIFFICULTY, CLICKING, ELEVATED METAL ION LEVELS, METALLOSIS, SWELLING AND SIGNIFICANT METAL DEBRIS AS WELL WITHIN THE GREATER TROCHANTER HAD A FAIRLY LARGE AREA IN THAT JUNCTURE. DOI: ON OR AROUND (B)(6) 2002 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 10706557 ↗
• InjuryOct 6, 2020Naturally Worn; Naturally Worn

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAIN, ELEVATED METAL ION LEVELS. OPERATIVE NOTES INDICATED EVIDENCE OF TRUNNIONOSIS WITH BLACK METAL DEBRIS AT THE TRUNNION. DURING OPERATION ANESTHESIA INFORMED THAT THE PATIENT WAS NOT DOING WELL IN FACT WENT INTO SEVERE BRADYCARDIA AND HYPOXIA AND AN EMERGENT CODE WAS CALLED AT WHICH POINT THEY SEALED THE WOUND WITH IOBAN EMERGENTLY FLIPPED THE PATIENT ONTO HIS BACK AND BEGAN CHEST COMPRESSION. THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND WAS STABLE AFTER MULTIPLE MEDICATIONS GIVEN. DOI: (B)(6) 2008, DOR: (B)(6) 2019, RIGHT HIP.

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

  MAUDE report 10638168 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS ADMITTED TO PVH LATE LAST NIGHT FOR A PERIPROSTHETIC FRACTURE OF HIS PROXIMAL FEMUR. UPON OPENING THE JOINT IT WAS DETERMINED THIS PATIENT NEED A PROXIMAL FEMUR REPLACEMENT. THE PATIENT ALSO HAD A METAL ON METAL HIP THAT WAS PUT IN OVER 20 YEARS AGO. THE METAL LINER WAS REMOVED AND REPLACED WITH A POLY LINER. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 10350618 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD , PATIENT WAS REVISED TO ADDRESS FAILED METAL ON METAL RIGHT TOTAL HIP ARTHROPLASTY. REVISION NOTES STATED THAT METAL STAINING OF THE SYNOVIUM AND CAPSULE WAS ENCOUNTERED AND AN EXTENSIVE SYNOVECTOMY PERFORMED UNDER DIRECT VISION. HEAD, LINER, AND CUP WERE REMOVED. PATIENT HAD ELEVATED METAL ION. DURING IMPLANTATION, THE PATIENT'S SURGERY WAS SIGNIFICANT FOR EXCESSIVE BLOOD LOSS (2000 ML), REPLACED WITH 3.5L OF CRYSTALLOID, 900ML VIA THE CELL SAVER AND 1 UNIT OF AUTOLOGOUS BLOOD. DOI: (B)(6) 2008 - DOR: (B)(6) 2018 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; No Code Available; Test Result

  MAUDE report 9842512 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED FOR OTHER MECHANICAL COMPLICATION OF INTERNAL JOINT PROSTHESIS. IT WAS INDICATED THAT THE PATIENT HAD METALLOSIS. OPERATIVE NOTES REPORTED THAT THERE WAS SIGNIFICANT AMOUNT OF BONE DESTRUCTION AND DEBRIS ENCOUNTERED INVOLVING THE PROXIMAL FEMUR. THERE WAS A LARGE AMOUNT OF NECROTIC MATERIAL DURING ACETABULAR INSPECTION. OPERATIVE FINDING REPORTED SEVERE OSTEOLYSIS. DOI: (B)(6) 2008; DOR: (B)(6) 2017; LEFT HIP. PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Foreign Body Reaction; Necrosis; No Code Available; Osteolysis

  MAUDE report 9834880 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION - ORIGINAL SURGERY (B)(6) 2016. REMOVED STEM, HEAD & LINER. PATIENT HAD A PERIPROSTETIC FRACTURE, COMPLAINED OF PAIN.

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

  MAUDE report 9616979 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S METAL ON METAL HIP CONSTRUCT WAS REVISED DUE TO PAIN. SURGEON REMOVED THE METAL LINER AND REPLACED IT WITH A POLY LINER. DOI: (B)(6) 2009; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Adhesion(s); Discomfort; Hypoesthesia; No Code Available; Pain; Test Result

  MAUDE report 9602299 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. UNF REPORTED THAT PATIENT HAD DEPUY PRODUCT REVISED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT HAD COMPLAINTS OF PAIN, DISCOMFORT, NUMBNESS AND ELEVATED METAL IONS. NO OPERATIVE RECORDS WERE PROVIDED FOR THE RIGHT HIP REVISION. DOI: (B)(6) 2009; DOR: (B)(6) 2018; RIGHT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE LEFT HIP

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

  MAUDE report 9601885 ↗
• InjuryJan 2, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SUFFERED A PERI-PROSTHETIC HIP FRACTURE. THERE WAS ALSO LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE SUMMIT STEM WAS REMOVED AND A RECLAIM HIP WAS PLACED. DOI: (B)(6) 2009; DOR: (B)(6) 2019; LEFT HIP.

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

  MAUDE report 9538808 ↗
• InjuryDec 27, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT BONE TO IMPLANT INTERFACE. SURGEON EXPLANTED COMPONENT REVISING WITH CEMENTED SUMMIT. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9526393 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6), 2010; DOR: NONE REPORTED RIGHT HIP. SEE (B)(4) LEFT HIP.

  Patient problems: Foreign Body Reaction; Test Result

  MAUDE report 9166492 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT. GENERAL LITIGATION NOTED METAL ON METAL IMPLICATIONS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. ADDED STEM DUE TO NEW ALLEGATION. ADDED LAW FIRM, REVISION SURGEON, REVISION HOSPITAL, PATIENT'S AGE, AND PATIENT'S DOB. UPDATED PRODUCT DETAILS OF UNKNOWN HEAD AND LINER. DOI: (B)(6) 2005, DOR: (B)(6) 2015 (LEFT HIP).

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

  MAUDE report 9163345 ↗