PINNACLE POROCOAT 1217-20-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295009641), received between Jan 17, 2019 and Jul 26, 2024 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON PERFORMED A HIP REVISION, PRIMARY HIP ARTHROPLASTY WAS PERFORMED IN 2018. PATIENT COMPLAINED OF HIP SLIPPING, SURGEON SUSPECTED THIS WAS DUE TO THE LINER BEING DISASSOCIATED FROM THE CUP. LINER AND CUP WERE EXPLANTED AND REPLACED WITH A TRIDENT CUP. DOI: 2018. DOE: (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 19839757 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRIMARY HIP WAS DONE ON (B)(6) 2009. METAL LINER / HEAD WERE REVISED ON (B)(6) 2020; REASON UNKNOWN. THE STEM/ SHELL /SCREW+ REVISION LINER + HEAD WERE REMOVED ON (B)(6) 2023 FOR INFECTION. THERE WAS OSTEOLYSIS AND A POLY WEAR REPORTED. DOI: (B)(6) 2009; (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17318335 ↗
• MalfunctionJul 25, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE PINNACLE, THE HEAD, AND THE SUMMIT POROCOAT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT CUP WAS LOOSENED. ADDITIONALLY, INFECTION WAS SUSPECTED. THEREFORE, ALL THE IMPLANTS WILL BE REMOVED. ON (B)(6) 2022, THE CUP AND THE STEM WILL BE REMOVED. ON (B)(6) 2022, IF THE PATIENT IS NOT INFECTED AND THERE IS NO PROBLEM, THE IMPLANTS WILL BE REPLACED WITH OTHER COMPANY¿S IMPLANTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 15092683 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HIGH COBALT LEVELS 171 ( METAL ON METAL HIP ). PSEUDO TUMORS WERE PRESENT. DOI: (B)(6) 2007. DOR: (B)(6) 2020. RIGHT SIDE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Necrosis; Osteolysis; Physical Asymmetry; Pulmonary Embolism; Swelling/ Edema

  MAUDE report 14084509 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTION, AND REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENTS MAY ALSO HAVE ARMD. INTRAOPERATIVELY, THE SURGEON IDENTIFIED EXTENSIVE FEMORAL AND ACETABULAR BONE LOSS. A NEW IMPLANT WILL BE REPLACED AFTER CEMENT BEADS ARE PLACED AND CRP IS LOWERED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI:UNK, DOR (B)(6) 2011 (B)(4), DOR: (B)(4) 2021, UNK HIP.

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

  MAUDE report 11984782 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE ¿PROSTHESIS FRACTURE¿ OF THE PINNACLE IMPLANT, AND SUBSEQUENT ¿REPLACEMENT OF THE STEM AND OF THE POLYETHYLENE LINER¿. THE ABOVE IMPACTED IMPLANT WAS IMPLANTED ON (B)(6) 2010 AFTER A REVISION AND REPLACEMENT OF THE ASR IMPLANT THAT THE PATIENT RECEIVED ON (B)(6) 2008. LITIGATION ALLEGES PROSTHETIC FRACTURE. PLAINTIFF IS SEEKING FULL COMPENSATION FOR ALL THE DAMAGES THAT HAD CAUSED HER SUCH AS PERMANENT BIOLOGICAL INJURY, IMPAIRED MOBILITY, LIMITED ADL, JOINT INSUFFICIENCY, FINANCIAL LOSSES AND SOCIAL INTERACTIONS DUE TO DEFECTIVE AND LACK OF SAFETY PRODUCTS IMPLANTED. DOI: (B)(6) 2008; DOR: (B)(6) 2019: RIGHT HIP 2ND REVISION (STEM). DOI: (B)(6) 2010; DOR: (B)(6) 2019; RIGHT HIP 2ND REVISION (CUP, LINER AND HEAD).

  Patient problems: Loss of Range of Motion

  MAUDE report 11223406 ↗
• InjuryDec 29, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PINNACLE SHELL WAS LOSS, PATIENT HAS SUSPECTED INFECTION. ACETABULAR REVISION WAS PERFORMED. FROZEN SECTIONS RESULTS WERE CHRONIC AND ACUTE INFLAMMATION. LOOSENING REPORTED AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Inflammation

  MAUDE report 11089717 ↗
• MalfunctionOct 6, 2020Defective Component; Defective Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING A PRIMARY SURGERY.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10636994 ↗
• InjuryJul 28, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT TOTAL HIP IN 2017, UNKNOWN DATE/HOSPITAL/SURGEON. IT WAS DONE IN A DIFFERENT GEOGRAPHIC LOCATION. PATIENT COMPLAIN OF HIP PAIN. DOI: 2017, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10332976 ↗
• InjuryFeb 19, 2020Malposition of Device; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 VIA THA OF THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE CUP, THE LINER, THE HEAD, AND THE STEM WITH THE SLEEVE DUE TO DISLOCATION CAUSED BY FALL DOWN. IT WAS CONFIRMED THAT THE CUP WAS IMPLANTED AT SUPERIOR SIDE OF THE ACETABULUM AT THE PRIMARY SURGERY AND THE LATERAL OPENING ANGLE WAS ABOUT 60 DEGREES. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 9727090 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, INJURIES, EMOTIONAL DISTRESS, DISABILITY AND DISFIGUREMENT. THERE HAS NO REVISION REPORTED. DOI: (B)(6) 2008; DOR: NOT REPORTED; RIGHT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; No Code Available; Pain; Pulmonary Embolism; Unspecified Infection

  MAUDE report 9139481 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. DOI: (B)(6) 2008; DOR: (B)(6) 2012; (RIGHT HIP).

  Patient problems: Discomfort; No Code Available; Pain; Rash; Unspecified Infection

  MAUDE report 9086459 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8256597 ↗