SUMMIT POROCOAT 1570-01-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10603295059349), received between Jan 13, 2015 and Apr 10, 2026 — classified as 85 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (8 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 88 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Osseointegration Problem

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED DUE TO THIGH PAIN, DUE TO A LOOSE UNDERSIZED SUMMIT TAPERED POROCOAT PRIMARY HIP ARTHROPLASTY FEMORAL STEM. THE PRIMARY STEM AND FEMORAL HEAD WERE REMOVED AND REPLACED BY A RECLAIM MONOBLOC REVISION STEM AND FEMORAL HEAD. LOOSING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24839067 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROXIMAL PERIPROSTHETIC FRACTURE FROM A FALL. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 24037874 ↗
• InjuryJan 8, 2026Naturally Worn

  IT WAS REPORTED FOLLOWING A HIP REVISION SURGERY, DURING WHICH A THIN MEMBRANE-LIKE STRUCTURE WAS OBSERVED BETWEEN THE METAL COMPONENT AND THE PLASTIC LINER. THIS STRUCTURE WAS SUSPECTED TO HAVE DETACHED FROM THE SURFACE OF THE METAL COMPONENT, THOUGH INSPECTION REVEALED THE INNER SURFACE AND LOCKING MECHANISM OF THE METAL COMPONENT APPEARED INTACT, AND THE COMPONENT WAS NOT REPLACED. THE PATIENT UNDERWENT REVISION SURGERY DUE TO A PSEUDOTUMOR AND RECOVERED WITHOUT COMPLICATIONS. THE PAIN SYMPTOMS AND NEED FOR REVISION WERE INTERPRETED AS UNRELATED TO THE MEMBRANE-LIKE CHANGE OBSERVED DURING THE PROCEDURE. THE ACETABULAR CUP WAS EXPLANTED AND DESTROYED AND IS NOT AVAILABLE FOR RETURN. OTHER COMPONENTS INVOLVED IN THE PRIMARY SURGERY INCLUDED SUMMIT POR TAPER SZ3 STD OFF, ARTICUL/EZE BALL 32 +9 BL, AND ALTRX +4 10D 32IDX48OD, ALL OF WHICH WERE ALSO EXPLANTED AND DESTROYED.

  Patient problems: Medical Device Site Inflammation; Pain

  MAUDE report 24002259 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY SURGERY WITH THE SUMMIT STEM AND THE CUP (NON-J&J PRODUCT). THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, RETROVERSION OF THE PINNACLE A (METAL-ON-METAL) CUP OCCURRED, AND ARMD WAS SUSPECTED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED. NECROTIC TISSUE SPREAD IN THE LARGE AREA OF SOFT TISSUE WERE REMOVED. A BLACK RING-SHAPED FOREIGN OBJECT WAS FOUND ATTACHED TO THE NECK PART OF THE SUMMIT. WHEN ATTEMPTING TO REMOVE THE HEAD, METAL LINER, AND 2 SCREWS, THE CUP WAS FOUND TO BE LOOSE, SO THEY WERE ABLE TO BE EASILY REMOVED BY HAND. A PINNACLE GRIPTION MULTI HOLE CUP 56 MM WAS FIXED WITH 5 SCREWS USING A COMPETITOR'S NAVIGATION. A 36 MM NEUTRAL LINER WAS INSTALLED, TRIAL HEADS WITH 36 MM+1.5 AND +5 WERE USED FOR FIXATION, AND THE +5 ONE WAS SELECTED EVENTUALLY. A DELTA TS HEAD WAS HAMMERED IN, AND THE REVISION WAS COMPLETED.

  Patient problems: Foreign Body Reaction; Necrosis; Unspecified Tissue Injury

  MAUDE report 21949316 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 19013617 ↗
• InjuryOct 31, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PATIENT WAS REVISED DUE TO THE STEM SUBSIDED AS IT WAS UNDERSIZED AND LOOSE AT THE BONE TO IMPLANT INTERFACE. THE STEM WAS REMOVED AND PUT IN A LARGER ONE. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18040064 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HIP REPLACEMENT IN (B)(6) OF 2020. THE PATIENT DID WELL INITIALLY BUT HAS HAD AN INFECTION IN HIP FOR APPROXIMATELY A YEAR ACCORDING TO THE SURGEON. ALL OF THE COMPONENTS WERE EXPLANTED AND A PROSTALAC SPACER WAS IMPLANTED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18031131 ↗
• InjuryAug 9, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO FEMUR FX AND STEM SUBSIDED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17489287 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTS AT EMERGENCY ROOM WITH DISLOCATED HIP AFTER HEMI-ARTHROPLASTY. PATIENT BROUGHT TO OR WHERE IT IS FOUND THAT THE REPAIR HAD BEEN TORN. SURGEON CHOSE TO CONVERT FROM A STD TO HIGH OFFSET STEM IN A ATTEMPT TO FURTHER INCREASE HIP STABILITY. TISSUES WERE REAPPROXIMATED AND REINFORCED. NO PATIENT HARM OCCURRED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 17405041 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED AND SPACER PUT IN FOR POSSIBLE INFECTION. IT WAS UNABLE TO DETERMINE INFECTION OR NOT. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17335152 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ALLEGES HAVING PROGRESSIVE PAIN IN HER RIGHT HIP THAT IS EXACERBATED BY WEIGHTBEARING ACTIVITIES. X-RAY SHOWED NO ABNORMALITIES, BUT THE METAL LEVELS REMAINED ELEVATED. REPEAT METAL LEVELS IN (B)(6) 2021 SHOWED THAT THE METAL LEVELS HAVE CONTINUED TO RISE. REVISION SURGERY HAS BEEN RECOMMENDED ON HER RIGHT HIP. THE CURVED OSTEOTOME/EASY OUT SYSTEM WAS UTILIZED IN STANDARD FASHION TO DISRUPT THE INTERFACE BETWEEN THE BONE AND THE ACETABULAR COMPONENT WHICH WAS NOTED TO BE OSSEOINTEGRATED. THERE WAS MINIMAL IATROGENIC BONE LOSS WITH REMOVAL OF THE ACETABULAR COMPONENT BUT GIVEN THE COMPONENTS PLACEMENT BOTH MEDIALLY AND RETROVERTED AND RELATIVELY LARGE SIZE FOR THE PATIENT'S ANATOMY THERE WAS NOT A LOT OF BONE REMAINING. DOI : (B)(6) 2010, DOR: (B)(6) 2021, RIGH HIP AFFECTED SIDE.

  Patient problems: Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 16120511 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. EXPLANT AND PLACEMENT OF SPACER WAS DONE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15567154 ↗
• MalfunctionJul 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM INSERTER GOT STUCK ON THE STEM. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 14986078 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED (B)(6) 2022. UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO METALLOSIS. OPERATIVES NOTES INDICATED PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS. UPON INCISION THERE WAS SMALL AMOUNT OF SLIGHTLY GRAY SYNOVIAL FLUID ENCOUNTERED. A MILD TO MODERATE METALLOSIS DEBRIS THROUGHOUT THE CAPSULE. THE MAJORITY OF THE METAL DEBRIS APPEARED TO ACTUALLY COMING FROM THE CUP/LINER ARTICULATION. DOI: (B)(6) 2005. DOR: (B)(6) 2021. LEFT HIP.

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

  MAUDE report 14642019 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION FOR RIGHT TOTAL HIP EXPLANT. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13802133 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT BHA SURGERY FOR THE FEMORAL NECK FRACTURE WITH IMPLANTS IN QUESTION. AFTER THE SURGERY, IT WAS CONFIRMED THAT PERIPROSTHETIC JOINT INFECTION OCCURRED. REMOVAL SURGERY WAS PERFORMED. THE PATIENT WILL UNDERGO A PROCEDURE OF PLACING ANTIBIOTICS IN THE AFFECTED AREA AND WILL UNDERGO RE-SURGERY OF BHA AFTER TREATMENT OF THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13215622 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. PATIENT WAS REVISED WAS DUE TO FAILED HARDWARE. RECORDS ALLEGES INJURIES, PAIN, METALLOSIS, DIFFICULTY WALKING, DISABILITY AND ELEVATED METAL IONS. DOI: (B)(6) 2005 DOR: (B)(6) 2021 LEFT HIP.

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

  MAUDE report 13023456 ↗
• MalfunctionAug 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  AFFECTED SIDE WAS THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270725 ↗
• InjuryJul 19, 2021Degraded; Degraded

  PATIENT EXPERIENCED DISCOMFORT, MANAGED SOCKS/SHOES WITH SOME DIFFICULTY. PATIENT HAS ENLARGING SUPRA- ACETABULAR CYST WHICH COULD BE RELATED TO METAL-ON-METAL FAILURE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Discomfort; Foreign Body Reaction; Loss of Range of Motion; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 12189706 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD DONE A HEMI HIP BI POLAR ON (B)(6) 2021. THIS PATIENT HAD FALLEN AND FRACTURED HIS PROXIMAL FEMUR EARLIER THIS WEEK. SURGEON PULLED THE STEM AND REPLACED THE CONSTRUCT APPLIED X3 CABLES. NO FURTHER INFO IS KNOWN OR AVAILABLE TO DEPUY AT THIS TIME. TO ANSWER QUESTION BELOW NO INSTRUMENTS WERE BROKEN AND THEREFORE NOTHING REMOVED FROM THE PATIENT. DOI: (B)(6) 2021: DOR: (B)(6) 2021: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12173317 ↗
• MalfunctionMay 20, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AFTER OPENING THE SUMMIT STEM, THE SURGEON NOTICED SOME FUZZ AROUND THE IMPLANT AND THOUGHT IT LOOKED ODD. PROCEEDED TO OPEN A NEW STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859046 ↗
• InjuryMay 4, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PROXIMAL PERIPROSTHETIC FRACTURE OF FEMUR AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS LOOSE DUE TO FRACTURE. THE PATIENT FELL AND CAUSE THE FRACTURE. DOI: (B)(6) 2021 DOR: (B)(6) 2021 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 11771397 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, ALL IMPLANTS WERE REMOVED AND PROSTALAC IMPLANTED. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11158094 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD, LINER EXCHANGE AND A COLLARED CORAIL STEM USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10678954 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

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

  MAUDE report 10517706 ↗