PINNACLE POROCOAT 1217-22-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 10603295009849), received between Nov 22, 2013 and Aug 31, 2026 — classified as 208 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (33 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 220 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to prostalac placement for infection. There was a removal of all implants.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50530855 ↗
• MalfunctionJan 9, 2026Device-Device Incompatibility

  SURGEON USED THE 56 CUP TRIAL FROM THE INSTRUMENT AND OPENED THE 56 IMPLANT BUT THE ACTUAL IMPLANT WAS NOT MATCHING WITH THE TRIAL SIZE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, IP-02624872. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023678 ↗
• InjuryNov 14, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WERE NO PATIENT CONSEQUENCE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23557049 ↗
• InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LINER DISASSOCIATED WITH THE CUP. SEVERE METALOSIS. DOI: (B)(6) 2012. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 23008793 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT. ON (B)(6) 2023, PATIENT UNDERWENT ASPIRATION RIGHT HIP DUE TO RIGHT PAINFUL TOTAL HIP ARTHROPLASTY. ON(B)(6) 2023, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO ADVERSE METAL REACTION AND ELEVATED COBALT LEVELS. THE PATIENT HAD INCREASE FATIGUE AND DEPRESSION THEN DEVELOPED TREMORS AND EVENTUALLY MORE PAIN. DURING OPERATIONS, RUSTY COLORED FLUID UPON INCISION INTO THE CAPSULE ALONG WITH NECROTIC RUSTY-STAINED TISSUE ON THE INSIDE OF THE CAPSULE WERE FOUND. FURTHERMORE, A FAIR AMOUNT OF BONE LOSS WAS NOTED AND BONE WAS EXTREMELY THIN AND RIDGE COULD BE PALPATED. IT WAS ALSO OBSERVED THAT THERE WAS CORROSION OCCURRING AT THE TAPER JUNCTION IN THE FEMORAL NECK. DOI:(B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SITE: RIGHT HIP.

  Patient problems: Bone Notching; Cramp(s) /Muscle Spasm(s); Depression; Fatigue; Foreign Body Reaction; Metal Related Pathology; Necrosis; Pain

  MAUDE report 22915805 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2013: SUBJECT REPORTED EVENT TO CLINICAL SITE FOR RIGHT HIP PAIN. PATIENT WAS TREATED BY STEROID INJECTION IN THE RIGHT HIP AND THIS EVENT REMAINS CONTINUING.

  Patient problems: Pain

  MAUDE report 22708650 ↗
• 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 22328562 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION HIP SURGERY DUE TO INSTABILITY. STEM WAS NOT REVISED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22232126 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT ORIGINALLY HAD A HIP REPLACED IN (B)(6) 2024. THE PATIENT DEVELOPMENT AN INFECTION IN THE RIGHT HIP. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH A PROSTALAC STEM.

  Patient problems: Unspecified Infection

  MAUDE report 22084808 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION DUE TO INFECTION. PSEUDOMONAS INFECTION, LIKELY AS A RESULT OF THE CANNULA DONE BY NURSING STAFF IN ICU. ALL IMPLANTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 21943819 ↗
• InjuryMar 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF A C-STEM PINNACLE. THE REASON FOR REVISION WAS BECAUSE THE STEM WAS LOOSE, AND THE HIP WAS UNSTABLE. NO ALLEGATION WAS MADE BY THE SURGEON IN RELATION TO THE LOOSE STEM. THE CEMENT/STEM INTERFACE WAS LOOSE. CEMENT BONE/BONE INTERFACE WAS SOUND. THE SURGEON NOTED THAT IT WAS A VERY DIFFICULT PRIMARY. IT WAS DONE BY A DIFFERENT SURGEON AND THEY STRUGGLED TO GET A SZ 1HO C-STEM IN. THE X-RAY SHOWED THAT DUE TO THE ANTERIOR-LATERAL APPROACH, THE STEM WAS PUT IN VARUS. THE HIP WAS UNSTABLE BECAUSE AT THE PRIMARY SURGERY, THE CUP WAS PLACED AT THE WRONG VERSION. THE CUP WAS EXPLANTED. IT WAS EXTREMELY WELL FIXED. THE LINER WAS EXPLANTED WITH THE SHELL, BUT THE LOT NUMBER IS UNREADABLE AS THE LINER WAS DAMAGED WHEN EXPLANTED. RECLAIM BIMENTUM WAS IMPLANTED. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 21687929 ↗
• InjuryJan 8, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR A LOOSE PRESSFIT ACETABULAR CUP. THE LOOSENING INTERFACE WAS NON-CEMENTED IMPLANT. THE CUP WAS REMOVED AND A NEW CUP, LINER AND HEAD WERE PLACED. THERE WERE NO DELAYS OR BROKEN EQUIPMENT. THERE WAS NO INFECTION. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21104922 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT?-- INFECTION, LOW-GRADE FEVER, SPILLAGE.

  Patient problems: Erythema; Fluid Discharge; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20462689 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. REVISED CUP TO EMPHASYS DUAL MOBILITY. UNKNOWN SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 20359053 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20206087 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO INFECTION. SURGEON REMOVED ALL PARTS INCLUDING A 56MM PINNACLE CUP, 36X56MM METAL LINER, 36MM METAL FEMORAL HEAD, SIZE 4 HIGH OFFSET SUMMIT FEMORAL STEM. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19454407 ↗
• InjuryApr 15, 2024Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  LINER BREAKAGE INTRA-OP. IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY TOTAL HIP REPLACEMENT. DURING IMPLANTATION, THE CERAMIC LINER'S EDGE WAS FOUND TO BE FRACTURED, THEN THE SURGEON REMOVED THE LINER WITH THE ACETABULAR CUP, ALL THE FRAGMENTS WERE RETRIEVED AND CLEARED. CHANGE ANOTHER LARGER SIZE LINER TO COMPLETE THE PROCEDURE. PROCEDURE TIME EXTENDED BY MORE THAN HALF AN HOUR.THE PATIENT WAS IN STABLE CONDITION NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105586 ↗
• MalfunctionMar 15, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER DID NOT MATCHED IN THE CUP.

  Patient problems: Insufficient Information

  MAUDE report 18911650 ↗
• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUP AND REAMER SIZING IS MISMATCHED¿. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661698 ↗
• 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: (B)(6) 2010, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18327290 ↗
• InjuryNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE OF THE ARDS BROKE OFF DURING THE REVISION, NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18140533 ↗
• InjuryNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE AN ARD BROKE OFF AND WAS FOUND DURING THE REVISION. SURGERY DELAY : NO; REVISION SURGERY : YES.

  Patient problems: Insufficient Information

  MAUDE report 18140391 ↗
• InjurySep 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED AS THE PINNACLE POLY HAVE DISASSOCIATED FROM PINNACLE CUP, CLASSIC SPIN OUT. NEW CUP AND POLY WERE INSERTED TO AVOID REPEAT OCCURRENCE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 17816176 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION OF THE RIGHT HIP IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17397902 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HIS RIGHT HIP REPLACED ON 2/1/23 AT ORTHOPEDIC SURGICAL INSTITUTE WHERE HE RECEIVED A SUMMIT PINNACLE CONSTRUCT. HE BEGAN TO EXPERIENCE SOME DISCOMFORT AND DRAINAGE COMING FROM HIS WOUND A FEW WEEKS AFTER SURGERY. THE PATIENT WAS BROUGHT IN FOR AN I&D AND IMMEDIATE EXCHANGE OF ALL COMPONENTS. THE SUMMIT STEM, HIP BALL, PINNACLE CUP, AND PINNACLE LINER WERE ALL EXPLANTED. THE WOUND WAS THOROUGHLY DEBRIDED AND NEW COMPONENTS WERE IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Fluid Discharge

  MAUDE report 16511997 ↗