PINNACLE POROCOAT 1217-22-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295009863), received between Sep 14, 2017 and Aug 28, 2026 — classified as 74 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (11 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 82 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had prostalac spacer for infection, right hip. Removal of all implants from original surgery date of (b)(6)2026. Affected side- Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50497384 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC REMOVAL OF IMPLANTS. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Sepsis

  MAUDE report 23634885 ↗
• InjuryNov 12, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO MALPOSITIONED CUP. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20669222 ↗
• MalfunctionJul 1, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA THA FOR FEMORAL HEAD NECROSIS FOR THE HIP JOINT. WHEN THE INSIDE (CLEAN SIDE) OF THE DOUBLE STERILIZATION OF THE PRODUCT IN QUESTION WAS OPENED, THE PART OF THE COVER THAT OPENS WAS STICKING OUT. THEREFORE, THE INNER COVER WAS ALSO OPENED IN THE UNCLEAN AREA, AND THE CLEANLINESS NURSE DIRECTLY PICKED UP THE PRODUCT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645135 ↗
• InjuryApr 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REVISION SURGERY WAS COMPLETED BECAUSE OF THE LINER DISASSOCIATION THAT WAS IDENTIFIED ON THE X-RAY.

  Patient problems: Insufficient Information

  MAUDE report 19099913 ↗
• InjuryJan 10, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT PATIENT EXPERIENCED A "POP" IN THE HOSPITAL IMMEDIATELY AFTER SURGERY. THEN FELT ANOTHER CLICK AND EXPERIENCED PAIN. INTRA OP DURING THE REVISION CONFIRMED THE POLY LINER WAS DISLODGED. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18483384 ↗
• MalfunctionAug 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO ALLEGATION AGAINST THE DEVICE. THE SURGEON JUST FELT LIKE HE WANTED THE ENHANCED GRIP FROM THE GRIPTION CUP SO THE POROUS CUP WAS WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665957 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2019 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17048953 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2015. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: REVISION; STEM, HEAD, LINER, AND CUP WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16610193 ↗
• MalfunctionJan 31, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IMPLANT PACKAGING DID NOT LOOK CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271618 ↗
• InjuryJan 3, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO THE CUP BECAME LOOSE CAUSING HIP PAIN. THERE WAS AN UNKNOWN LOOSENING IN CUP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2020. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16085886 ↗
• InjuryAug 17, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION SO THE DOCTOR DID A ONE STAGE REIMPLANTATION WITH NEW COMPONENTS AFTER A COMPLETE WASHOUT. NO SURGICAL DELAY. THERE WAS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 15241121 ↗
• InjuryJul 25, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO METAL ION ELEVATED BLOOD LEVELS. DOI: UNKNOWN. DOR: (B)(6) 2021. (LEFT HIP). UPDATE AD 11 JUL 2022: IN RELATION TO AEI NOTE (B)(4), (B)(4)HAS BEEN RE-OPENED DUE TO PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES METAL POISONING DUE TO ELEVATED METAL IONS RESULTING TO HIP PAIN, DISCOMFORT, THICK CAPSULE AND FLUID IN THE LEFT HIP, METAL DEBRIS, REMOVAL OF THE LARGE AMOUNT OF BROWN INTRA-ARTICULAR FLUID, EXCISION OF METALLOSIS TISSUE AROUND THE ACETABULAR CUP, DEBRIDEMENT OF METALLOSIS TISSUE AROUND THE METAL LINER AND NECK, EMOTIONAL TRAUMA AND DISTRESS.

  Patient problems: Adhesion(s); Discomfort; Distress; Fatigue; Foreign Body Reaction; Muscular Rigidity; Numbness; Pain; Swelling/ Edema

  MAUDE report 15096175 ↗
• InjuryJun 17, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF RIGHT TOTAL HIP, SUMMIT STEM, 40 -2 HEAD AND 40 METAL ON METAL LINER WITH 60 PINNACLE SECTOR CUP. ONLY THE SUMMIT STEM WAS RETAINED. CUP, LINER, HEAD, BONE SCREW WERE EXPLANTED. A BIOMET CUP WAS PUT IN WITH BIOMET LINER. 40 +8.5 CERAMIC TS HEAD WAS PLACED ON SUMMIT STEM. EXPLANATION FOR REVISION WAS NOT PROVIDED TO THE REPRESENTATIVE. IT WAS NOT NOTED AT THE TIME OF SURGERY THAT THERE WAS A DEFICIENT PRODUCT. IT WAS NOTED BY THE SURGEON IT IS A METAL ON METAL LINER. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Cellulitis; Cyst(s); Fever; Foreign Body Reaction; Metal Related Pathology; Neuralgia; Pain; Swelling/ Edema

  MAUDE report 14734560 ↗
• MalfunctionJun 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT OPERATING ROOM STAFF COLLECTED AN IMPLANT BOX THEY'VE REMOVED THE PLASTIC BUT THE IMPLANT INCLUDED IN THE BOX WAS THE WRONG IMPLANT. THEY HAVE TRIED TO IMPLANT THIS ITEM IN THE PATIENT, BUT IT WAS IMPOSSIBLE. THEY'VE OPENED A NEW IMPLANT AND FINISHED THE SURGERY. THERE WAS A 10 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 14685716 ↗
• InjuryMay 20, 2022Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 14455636 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED STAGE 1 LEFT TOTAL HIP REVISION DUE TO INFECTION. REMOVAL OF CORAIL STEM, HEAD, PINNACLE CUP, SCREW AND LINER. DOI: UNKNOWN. DOR: (B)(6) 2022. LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14166439 ↗
• InjuryApr 1, 2022Use of Device Problem; Use of Device Problem

  TOTAL HIP REPLACEMENT REVISION DUE TO POSTERIOR DISLOCATION. PREVIOUS REVISION OF PRIMARY LINER TO CONSTRAINED LINER WAS ON (B)(6) 2021. ENTIRE CONSTRUCT, INCLUDING FEMUR, WAS REVISED AS WHEN THE HEAD WAS REMOVED THE STEM CAME OUT AT THE SAME TIME. REASON FOR REVISION WAS RECURRENT DISLOCATION. DOI: UNKNOWN; 1ST DOR: (B)(6) 2021; 2ND DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 13975679 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD THA ON (B)(6) 2021. THE SURGEON IMPLANTED A SUMMIT / PINNACLE HIP CONSTRUCT. THE PATIENT BEGAN TO EXPERIENCE PAIN AND DISCOMFORT WITH DRAINAGE IN AND AROUND THE WOUND. THE SURGEON EXPLANTED THE HIP CONSTRUCT AND IMPLANTED A PROSTALAC HIP CONSTRUCT. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Fluid Discharge; Pain

  MAUDE report 13251270 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN AND AGONY IN HIS RIGHT HIP AND LOWER EXTREMITY FOR WHICH HE CONTINUES TO SEEK MEDICAL TREATMENT. DIO: (B)(6) 2010 - DOR: NONE REPORTED (RIGHT HIP). UPDATE AD 30 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF, IMPLANT RECORDS, AND MEDICAL RECORDS. THERE WERE NO NEW ALLEGATIONS AND NO REVISION REPORTED. AFTER REVIEW OF MEDICAL RECORDS, REVISION NOTES REPORTED. ADDED PATIENT'S DOB AND LAW FIRM. UPDATED PATIENT'S INITIALS, AND PRODUCT DETAILS OF UNKNOWN LINER AND HEAD. DOI: (B)(6) 2010 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Fatigue; Pain

  MAUDE report 12433394 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE HIP. DOI:(B)(6) 2004 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 12127236 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP; REMOVED ALL COMPONENTS; PERFORMED I&D AND RE-IMPLANTED NEW COMPONENTS. DOI: (B)(6) 2021. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11726954 ↗
• InjuryApr 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS METALLOSIS AND LOOSE FEMORAL STEM. DURING CLINICAL VISITS, PATIENT HAS MILD LEG LENGTH DISCREPANCY, SCAR AND PAIN ON EXAM AND RADIOGRAPHS REVEALED ECCENTRICALLY PLACED METAL LINER. REVISION NOTES STATED THAT THERE WAS MINIMAL SCAR, SMALL AMOUNT OF JOINT FLUID WAS ENCOUNTERED. FIBROUS TISSUE WAS REMOVED AT THE CUP AND LINER. IT WAS MENTIONED THAT THE METAL IONS WERE ELEVATED HOWEVER RESULT SHOWS BELOW 7PPB. DOI: (B)(6) 2007 - DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain; Physical Asymmetry

  MAUDE report 11602026 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REASON FOR REVISION ARE INFECTION AND POSTERIOR DISLOCATION. REASON FOR DISLOCATION UNDETERMINED. NO OTHER INFORMATION AVAILABLE. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 11281157 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM LETTER RECEIVED. PATIENT ALLEGES CONSTANT PAIN, WALKING DIFFICULTY AND ABSCESS WHICH RESULTED IN A REVISION OF THE RIGHT HIP. DOI: (B)(6) 2009; DOR: (B)(6) 2020; (RIGHT HIP).

  Patient problems: Abscess; Anxiety; Foreign Body Reaction; Metal Related Pathology; No Code Available; Pain

  MAUDE report 10788246 ↗