SUMMIT POROCOAT 1570-01-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 10603295059370), received between Jul 16, 2015 and Sep 18, 2026 — classified as 158 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (16 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 164 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient is infected. Taking out all hip implants and converting to a spacer.Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50825945 ↗
• InjurySep 18, 2026Osseointegration Problem; Migration

  Patient problems: Inadequate Osseointegration

  MAUDE report 50822030 ↗
• InjuryDec 11, 2025Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A FAILED LEFT TOTAL HIP REPLACEMENT SURGERY DUE TO ARTICULAR BEARING WEAR, ELEVATED COBALT LEVELS AND AN ADVERSE REACTION TO ARTICULAR WEAR. INTRAOPERATIVE FINDINGS DESCRIBED MODERATE CLEAR EFFUSION WITH BROWN STAINING AND DEBRIS OF THE INNER LINING. PSEUDOMEMBRANE WAS STAINED AND DEBRIS WAS DEBRIDED. AFTER REMOVAL OF THE HEAD, THERE WAS CONSIDERABLE BLACK CORROSION DEBRIS AT THE BUNION EDGE CONSISTENT WITH FAILURE OF THE ASR. DOI: (B)(6) 2009, DOR: (B)(6) 2024, LEFT HIP.

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

  MAUDE report 23780458 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED LEGAL RECORDS WERE RECEIVED. THERE IS GAS AND SOFT TISSUE SWELLING SURROUNDING THE LEFT PROXIMAL FEMUR COMPATIBLE WITH POSTOPERATIVE CHANGES. LOOSENING OF FEMORAL COMPONENT OF PROSTHETIC LEFT HIP, SYNOVIAL FLUID FROM HIP JOINT, LEFT ARTHRITISM, PROGRESSIVE HIP PAIN AND DISABILITY. 10 ML OF BLACK STAINED FLUID, ACUTE METAL WEAR PROCESS, POLYETHYLENE LINER WAS WORN THROUGH SUPERIORLY AND BROKEN IN THE SUPERIOR RIM. THE CERAMIC BALL WAS NOTED TO HAVE BLACK STAINING ON THE SUPERIOR SURFACE, WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT HIP JOINT, INITIAL ENCOUNTER (CMS/HCC). HAD SEVERE BACK PAIN/MUSCLE SPASMS. COBALT LEVEL OF 77.1 AND A CHROMIUM LEVEL OF 40.1. DURING THE PROCEDURE, APPROXIMATELY 9 ML OF YELLOWISH FLUID WERE REMOVED. MODERATE AMOUNT OF SCAR TISSUE WHICH WAS STAINED BLACK CONSISTENT WITH A METAL STAINING. SCAR TISSUE WAS EXCISED AROUND THE TRUNNION AND THE ACETABULUM CIRCUMFERENTIALLY. LEFT HIP SORENESS, WEAKNESS, AND DECREASED RECALL OF POSTERIOR. FIBROSIS, FOCAL INFARCTION AND HISTIOCYTIC REACTION SPECIMEN SUBMITTED AS SYNOVIAL SCAR TISSUE CONSISTS OF AN IRREGULAR RUBBERY SEGMENT OF TAN GRAY-RED SOFT TISSUE RECEIVED IN FORMALIN MEASURING

  Patient problems: Adhesion(s); Discomfort; Fatigue; Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 23692851 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HER HIP REPLACED RECENTLY AND COME INTO THE ER WITH AN INFECTION. THE SURGEON EXPLANTED ALL OF HER COMPONENTS AND DID A THOROUGH I&D AND REIMPLANTED A NEW STEM, CUP, DUAL MOBILITY HEAD AND LINER. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22980035 ↗
• InjuryJun 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED FOR DISLOCATION. DURING SURGERY IT WAS DETERMINED THE CUP WAS NOT IN A GOOD POSITION, AND THE STEM WAS SEATED TOO LOW. ALL COMPONENTS WERE REMOVED. A NEW CUP, LINER, STEM, AND HEAD WAS IMPLANTED. AFFECTED AREA: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22329512 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL REPORT RECEIVED. DURING THE (B)(6) 2019 PRIMARY, IT WAS NOTED THAT A REAMER WAS PLACED AND IN DOING SO THERE WAS A PERFORATION POSTEROMEDIALLY. AT THIS POINT, THE SURGEON ELECTED TO USE A LONGER STEM TO BYPASS THE PERFORATION, SO THE SUMMIT STEM SYSTEM WAS OPENED. ON (B)(6) 2019 THE PATIENT WENT TO GET UP FROM A CHAIR AND FELT PAIN. IT WAS FOUND SHE HAD AN AVULSION FX OF THE LESSER TROCHANTER. SHE ALSO HAD A SYNCOPAL EPISODE SOMETIME BETWEEN (B)(6) AND (B)(6), PLAN IS TO CONTINUE WEIGHTBEARING AND PHYSICAL THERAPY. ON (B)(6) 19 A CT SCAN REVEALED A FLUID COLLECTION LATERAL TO THE PROXIMAL FEMUR, WHICH WAS MOST LIKELY A HEMATOMA OR SEROMA. HETEROTOPIC OSSIFICATION IN THE AREA OF THE ILIOPSOAS RELATED TO PREVIOUS FX WAS ALSO IDENTIFIED. THE PATIENT HAD MULTIPLE INJECTIONS OVER THE GREATER TROCHANTER FOR PAIN DUE TO TROCHANTERIC BURSITIS. THESE INJECTIONS OCCURRED ON (B)(6) 2019, (B)(6) 2020, (B)(6) 2020, AND (B)(6) 2021. ON (B)(6) 2020, THE PATIENT UNDERWENT AN EXCISION OF A LEFT HIP FOR A SUSPECTED SEROMA. A SEROMA WAS NOT IDENTIFIED BUT THE SURGEON DID FIND SCAR TISSUE. SEPARATE COMPLAINTS WILL BE CREATED FOR THE FEMORAL PERFORATION BY THE REAMER AND FOR THE AVULSION FRACTU

  Patient problems: Adhesion(s); Extraskeletal ossification; Hematoma; Limb Fracture; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 20350846 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Limb Fracture

  MAUDE report 20345391 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. SURGEON REMOVED SUMMIT STEM & HEAD. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 20299969 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP PAIN WITH BURSITIS AND ALVAL. OPERATIVE NOTES REPORTED COPIOUS YELLOW TINGED CLEAR FLUID FROM THE BURSA, DEFICIENCY IN THE ANTERIOR ABDUCTORS APPROX. 20 %. THERE WAS INFLAME SYNOVIUM AND THIS WAS REMOVED. THERE WAS A SMALL AMOUNT OF SCUFFING IN THE ACETABULUM AND IN THE SUPERIOR QUADRANT ON THE PERIPHERAL ASPECT OF THE BEARING SURFACE CAUSING METAL DEBRIS. DOI: (B)(6) 2008. DOR:(B)(6) 2010. AFFECTED AREA: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Inflammation; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19635031 ↗
• InjuryJun 12, 2024Adverse 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 PAIN. IT WAS UNKNOWN WHETHER THERE WAS ANY LOOSENING. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP

  Patient problems: Pain

  MAUDE report 19519584 ↗
• MalfunctionApr 15, 2024Naturally Worn; Naturally Worn

  PC WAS CREATED DUE TO PATIENT ALLEGED TRACES OF METAL SHAVINGS IN HIS BLOOD LEFT HIP. DOI: (B)(6) 2009. DOR: UNKNOWN. RIGHT HIP. BILATERAL: THIS PC WAS LINKED TO (B)(4). LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19104541 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA WITH THE CUP, HEAD, LINER, AND STEM IN QUESTION. ON AN UNKNOWN DATE, IT WAS CONFIRMED THAT THE PATIENT WAS RIDING A BICYCLE AND FELL, RESULTING IN A PERI-STEM FRACTURE. THEREFORE, ON (B)(6) 2023, REVISION SURGERY IS SCHEDULED. THE HEAD AND STEM WILL BE EXTRACTED, THE LINER WILL BE REPLACED, AND THE STEM WILL BE REPLACED WITH A ZIMMER ARCOS STEM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18398256 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE THA IMPLANTS WERE REPLACED WITH A PROSTALAC HIP. SURGICAL DELAY WAS UNKNOWN. DOI: ON (B)(6) 2010, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18327234 ↗
• InjuryDec 7, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023. LARGE METAL REACTION IN THE HIP JOINT. OSTEOLYTIC DEFECTS ON THE FEMUR AND ACETABULUM. DEFECTS OF THE ACETABULAR RIM FROM 12 TO 3 (SUPERIOR AND POSTERIOR) CUP WITH AUGMENT USED TO RECONSTRUCT ACETABULUM. THE FASCIAL LAYER WAS INCISED AND UNDERNEATH THERE WAS A DARK GRAY-COLORED FLUID. THE POSTERIOR REPAIR WAS TAKEN DOWN AND MORE FLUID WAS NOTED IN THE HIP JOINT. THERE WAS A LYSIS AROUND THE ACETABULUM AND AROUND THE FEMUR, AROUND 1.5CM OF OSTEOLYSIS. THERE WAS CORROSION AROUND THE TRUNNION. AS MUCH LYSIS TISSUE WAS REMOVED AS POSSIBLE AS WELL AS MUCH OF THE METAL DEBRIS AS POSSIBLE. THE SURGEON CONTINUED THE DEBRIDEMENT AROUND THE CUP. IT WAS NOTED TO HAVE OSTEOLYSIS ON THE CUP. IT WAS NOTED TO HAVE BONY DEFECTS FROM AROUND 12-3 O'CLOCK ON THE FACE OF THE ACETABULUM POSTERIOR AND SUPERIOR.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 18283875 ↗
• InjuryDec 7, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE SURGEON DISCOVERED THERE WAS A LARGE FLUID-FILLED CAPSULAR EXTENSION TO THE AREA. THE CAPSULE WAS OPENED AND WAS NOTED TO HAVE A LARGE AMOUNT OF CLOUDY YELLOW-WHITE FLUID WITH SOME DEBRIS WITHIN IT. THE PSEUDOCAPSULE WAS NOTED TO BE INFLAMED. THERE WAS METAL DEBRIS AROUND THE NECK OF THE STEM. THERE WAS OSTEOLYSIS TRACKED INTO THE CANAL BUT ABOUT 15MM. THERE WAS OSTEOLYSIS NOTED BY THE CALCAR. THERE WERE AREAS BEHIND THE CUP THAT HAD SOME METAL DEBRIS.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Inflammation; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18283607 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. THE PATIENT HAD A RUPTURED DISK FROM HIP REVISION RECOVERY. DOI: (B)(6) 2008 (FOR STEM). DOI: (B)(6) 2022 (FOR HEAD). DOE: UNKNOWN. RIGHT HIP.

  Patient problems: Nerve Damage

  MAUDE report 17938660 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: PATIENT SUSTAINED PHYSICAL INJURIES IN HIS TENDONS, LIGAMENTS, TISSUES AND BONES WITHIN HIS RIGHT HIP. PATIENT SUFFERED FROM PRESSURE IN HIS RIGHT HIP AND INTERMITTENT DISCOMFORT. SUFFERED ELEVATED COBALT AND CHROMIUM LEVELS AS WELL AS TRUNNIONOSIS. SURGEON INFORMED THE PATIENT TO HAVE REVISION. DURING REVISION, SURGEON FOUND METALLOSIS THROUGHOUT THE HIP AND ALSO OSTEOLYSIS. PATIENT EXPERIENCE SOME PERSISTENT WEAKNESS AND STIFFNESS AND CLICKS WHEN WALKING. PATIENT HAVE ANXIETY ABOUT THE DAMAGE THAT THE ASR CAUSED AND FUTURE DAMAGE THAT THE HIGH ION LEVELS AND METAL IN HIS BLOODSTREAM.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Fatigue; Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Muscular Rigidity; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 17435193 ↗
• MalfunctionJun 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT STEM INSERTER STUCK IN STEM DURING IMPACTION. IT BACKED THE STEM OUT AND WOULD NOT LET GO. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210941 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED, ON (B)(6) 2017 MRI WAS NOTED TO SHOW HETEROTOPIC BONE FORMATION SUPERIOR TO THE GREATER TROCHANTER AND ALSO AN EXOSTOSIS AT THE LEVEL OF THE GRATER TROCHANTER. THE SURGEON¿S IMPRESSION IS THE PATIENT HAS A LEFT TOTAL HIP ARTHROPLASTY WITH NO EVIDENCE FOR HARDWARE FAILURE OR OF OSTEOLYSIS. THERE IS A SMALL JOINT EFFUSION AND DEHISCENCE OF THE CAPSULE WITH FLUID OVER A PORTION OF THE GREATER TROCHANTER AND SEPARATION OF CORRESPONDING PORTIONS OF THE GLUTEUS MINIMUS AND GLUTEUS MEDIUS TENDONS. THE PATIENT CONTINUED TO HAVE PAIN AND ABDUCTOR WEAKNESS. THE PATIENT RECEIVED A STEROID INJECTION. DOI: (B)(6) 2011; DOE: (B)(6) 2017; LEFT HIP.

  Patient problems: Extraskeletal ossification; Fatigue; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 16833724 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED DOING A SINGLE STAGE REIMPLANTATION. THERE WAS NO LOOSENING. CEMENT MANUFACTURER WAS NON-CEMENTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16521758 ↗
• InjuryFeb 13, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSE FEMORAL STEM. LOOSENING INTERFACE WAS NON CEMENTED. SURGICAL DELAY WAS REPORTED UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16368196 ↗
• InjuryNov 9, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAS A BIPOLAR HEMI ARTHROPLASTY . SHE FELL AND SUFFERED A PERIPROSTHETIC FRACTURE OF HER LEFT HIP. SHE WAS BROUGHT TO SURGERY AND THE SUMMIT STEM WAS REMOVED AND A 10 INSOLUTION BIPOLAR WAS PLACED. THERE WAS A LOOSENING REPORTED AT FEMUR STEM. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE : LEFT HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 15760209 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POSSIBLE INFECTION. INFECTION IS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15564097 ↗
• InjuryAug 16, 2022Naturally Worn; Naturally Worn

  70-YEAR-OLD FEMALE PATIENT RECEIVED A LEFT HIP REVISION TO TREAT IMPINGEMENT SECONDARY TO DISLOCATION AND LINER DISASSOCIATION. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED METALLOSIS CAUSED BY METAL DEBRIS. THE LINER WAS DISASSOCIATED DUE TO LOCKING MECHANISM FAILURE, CAUSING THE SUMMIT FEMORAL STEM TO IMPINGE ON THE FAILED LOCKING RING GENERATING WEAR ON THE TRUNNION AND METAL DEBRIS. THE CUP AND STEM WERE WELL-FIXED AND RETAINED. THE PATIENT A BIMENTUM DUAL MOBILITY ARTICULATING SURFACE TO REPLACE THE REVISED HEAD AND LINER. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. HEAD, LINER AND STEM WERE REVISED. DOI: (B)(6) 2008(CUP, STEM). DOI: (B)(6) 2017(HEAD, LINER). DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Foreign Body Reaction; Unspecified Musculoskeletal problem

  MAUDE report 15232291 ↗