PINNACLE POROCOAT 1217-20-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295009610), received between Aug 14, 2018 and Sep 20, 2024 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PRIMARY SURGERY WAS PERFORMED. AFTER THE SURGERY, THE DISLOCATION WAS CONFIRMED. THE EVENT DATE IS UNKNOWN. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016, TO REPLACE THE LINER, THE HEAD AND THE STEM. AFTER THE REVISION SURGERY, THE LINER IN QUESTION WAS BROKEN. THE EVENT DATE IS UNKNOWN. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023, TO REPLACE THE CUP, THE HEAD AND THE STEM IN QUESTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20273027 ↗
• InjuryJul 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT RETURN FOR AN X-RAY AS PART OF FOLLOW UP AND IT WAS IDENTIFIED THAT THE IMPLANT WAS FRACTURED. A REVISION SURGERY WAS ARRANGED AND PERFORMED ON (B)(6) 2023. UPON REMOVAL, THE IMPLANT WAS FOUND TO BE FRACTURED AND 2 OTHER DEVICES WERE FOUND TO BE SCRATCHED. PINNACLE POROCOAT MULTIHOLE COATING SCRATCHED OFF SURFACE. ALTRX LINER CRACKED. CERAMIC HEAD SURFACE SCRATCHED. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 17397416 ↗
• MalfunctionMar 8, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT THE PRIMARY THA SURGERY WITH THE CUP, THE STEM AND THE HEAD IMPLANTS IN QUESTION. AFTER THE SURGERY, IT WAS CONFIRMED THAT OSTEOLYSIS SUSPECTED TO BE ARMD AT THE BACK OF THE CUP ON AN UNKNOWN DATE. A REVISION SURGERY IS PLANNED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 13693649 ↗
• InjuryOct 21, 2019Malposition of Device; Device Dislodged or Dislocated; Naturally Worn; Malposition of Device; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON WAS SCHEDULED TO DO AN ABDUCTER TENOTOMY REPAIR. WHEN HE OPENED THE PATIENT HE FOUND METAL DEBRIS FROM THE STEM IMPINGING ON THE POSTERIOR PART OF THE CUP AND LINER. HE DECIDED TO REMOVE THE CUP, LINER, SCREW; AND HEAD, TO REPOSITION IN THE PROPER PLACE TO GIVE ADEQUATE STABILITY AND STOP THE IMPINGEMENT ON THE STEM. THE SUMMIT STEM WAS RETAINED. WE REAMED THE ACETABULUM UP TO A 56, PUT IN A 56 GRIPTION MULTI, AND IMPLANTED LINER AND HEAD TO FINISH THE CASE. THE SURGEON REQUESTED THE IMPLANTS BACK TO GIVE TO THE PATIENT. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Disorder; No Code Available; Not Applicable

  MAUDE report 9213439 ↗
• InjuryApr 16, 2019Malposition of Device; Malposition of Device

  LITIGATION ALLEGES PAIN AND MISPOSITIONED CUP. DOI: (B)(6) 2006 - DOR: (B)(6) 2014 (LEFT HIP).

  Patient problems: No Code Available; Pain; Scarring

  MAUDE report 8518946 ↗
• InjuryApr 16, 2019Malposition of Device; Malposition of Device

  LITIGATION ALLEGES PAIN AND MISPOSITIONED CUP. DOI: (B)(6) 2007 - DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 8518936 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGED INCREASED BLOOD HEAVY METAL IONS DUE TO THE FRICTION AND WEAR BETWEEN THE HEAD AND LINER, SEVERE PAIN, DISCOMFORT AND INFLAMMATION. DOI: (B)(6) 2008; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Discomfort; Fatigue; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Necrosis; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8431731 ↗
• InjuryFeb 5, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN. UPDATE 07 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP. DOI: (B)(6) 2009 - DOR: (B)(6) 2010, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8304525 ↗
• InjuryJan 15, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP AND METALLOSIS. DOI: (B)(6) 2007, DOR: FEB 19, 2010, (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 8247483 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8053057 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS WERE REMOVED DURING HIP REVISION SURGERY ON FRIDAY (B)(6) BY MR (B)(6). THE SURGEON HASN¿T REQUESTED ANY FURTHER INFORMATION. PELVIC DISCONTINUITY WAS THE REASON FOR REVISION. THE LOT NUMBERS WEREN¿T READABLE ON THE EXPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 7994474 ↗
• InjuryAug 14, 2018Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  LITIGATION PAPERS ALLEGE: PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN THE LEG, A POPPING AND CLICKING SOUND IN THE HIP; THE SENSATION THAT THE IMPLANT IS UNSTABLE AND WILL GIVE OUT; INABILITY TO WALK MODERATE OR LONG DISTANCES; INABILITY TO SLEEP ON PATIENT'S SIDE WITHOUT SEVERE PAIN; INABILITY TO SIT FOR MODERATE TO LONG PERIODS OF TIME; METALLOSIS; COBALT-CHROMIUM METAL TOXICITY; INFECTION; AND OTHER COMPLICATIONS. PPF ALLEGES LOOSENING OF CUP, METAL WEAR AND METALLOSIS. IT WAS ALSO INDICATED IN THE PPF THAT CUP, LINER, HEAD AND STEM WERE REVISED. DOI: (B)(6) 2005; DOR: (B)(6) 2005; (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Not Applicable; Pain; Unspecified Infection

  MAUDE report 7780934 ↗