PINNACLE POROCOAT 1217-20-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295009627), received between Dec 12, 2017 and Jun 3, 2022 — classified as 16 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PATIENT COMPLAINTS OF PAIN. METALLOSIS IS SUSPECTED. HEAD, LINER, AND STEM REVISED. DOI: 2010. DOR: (B)(6) 2022.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 14597103 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS DISCHARGED 6 DAYS AFTER THE IMPLANTATION. 16 DAYS AFTER THE SURGERY, THE PATIENT SUFFERED FROM ERYTHEMA, INFLAMMATION AND PAIN, HEAT. ON (B)(6), LOCAL REDNESS, SWELLING, HEAT PAIN AND WOUND EXUDATION DISAPPEARED AND DISCHARGED. ON (B)(6), MASS AND PAIN OCCURRED AGAIN IN THE ORIGINAL INCISION AND THE PATIENT WAS HOSPITALIZED FOR THE THIRD TIME. AFFECTED SIDE WAS THE LEFT SIDE.

  Patient problems: Erythema; Inflammation; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 12860094 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED BY METAL ON METAL SYSTEM ON (B)(6) 2009 VIA THA BY USING THE PINNACLE CUP 52MM, THE METAL LINER 36MM, THE HEAD 36MM±0, THE C-STEM SIZE3A, THE END CAP, THE CENTRALIZER, THE CEMENT RESTRICTOR SIZE4 (P/NS: UNKNOWN). IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2019 BY REPLACING THE CUP, THE STEM DUE TO PAIN THAT MAY BE CAUSED BY LOOSENESS WITH METALLOSIS ON THE ACETABULAR SIDE ESPECIALLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Not Applicable; Pain

  MAUDE report 9670756 ↗
• InjuryAug 26, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration 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. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES DISLOCATION, LOOSENING OF THE CUP AND FRACTURED BONE. THE CUP AND THE 5 SCREWS WERE ADDED TO THE IMPACTED PRODUCT DUE TO ALLEGED LOOSENING. THE UNKNOWN HIP IMPLANT HAS BEEN ADDED TO CAPTURED THE ALLEGATION OF A FRACTURE AS ITS UNKNOWN WHERE THE FRACTURE WAS. IF/WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED. DOI: (B)(6) 2010 - DOR: (B)(6) 2010, (LEFT HIP), SECOND REVISION.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8932615 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, DROPPED FOOT, METALLOSIS, ELEVATED BLOOD COBALT AND CHROMIUM, POPPING AND CLICKING SENSATION IN THE HIP, WEAKNESS, SEROMA AND PSEUDOTUMOR. PREOPERATIVE IMAGING SHOWED A 1CM LEG LENGTH DISCREPANCY AS WELL AS A SIGNIFICANT AMOUNT OF SHUCK. OPERATIVE FINDINGS INCLUDE METALLOSIS AT THE IT BAND, DARK BLOODY STAINED FLUID, SIGNIFICANT AMOUNT OF REACTIVE POCKETS OF FLUID, MULTIPLE AREAS OF SYNOVITIS, EXTENSIVE METALLOSIS WITHIN THE HIP JOINT, SMALL POCKETS OF HETEROTROPHIC OSSIFICATION AND SCARRING. THERE WAS NO EVIDENCE OF TRUNNIONOSIS OR FRETTING. DOI: (B)(6) 2006 - DOR: (B)(6) 2015, (RIGHT HIP).

  Patient problems: Foreign Body In Patient; No Code Available; Pain; Scarring; Weakness

  MAUDE report 8757601 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT COMPLAINED THE PAIN AFTER ABOUT 1 YEAR FROM THE PRIMARY SURGERY. THE SURGEON RECOGNIZED THAT THERE WAS VARUS TENDENCY AND SKIN THINNING TENDENCY. THE PATIENT WAS UNDER OBSERVATION, BUT IT WAS REPORTED THAT THERE WAS A POSSIBILITY OF THE REVISION SURGERY TO BE PERFORMED BY REPLACING THE CUPS, THE LINERS, THE HEADS AND THE STEMS FROM THE PATIENT¿S BOTH SIDE HIP JOINT. (DATE OF REVISION SURGERY WAS NOT FIXED YET).

  Patient problems: Pain

  MAUDE report 8270101 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PULMONARY EMBOLISM. DOI: (B)(6) 2003 - DOR: (B)(6) 2016 (LEFT HIP).

  Patient problems: No Code Available; Pain; Pulmonary Embolism; Tissue Damage

  MAUDE report 8267310 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PULMONARY EMBOLISM. DOI :(B)(6) 2005 DOR: (B)(6) 2016 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Pulmonary Embolism; Tissue Damage

  MAUDE report 8267280 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD ALLEGES FRICTION AND WEAR, LARGE AMOUNTS OF TOXIC COBALT AND CHROMIUM METAL IONS, PAIN, DISCOMFORT, FUNCTIONAL DIFFICULTIES AND ELEVATED METAL LEVELS.

  Patient problems: Discomfort; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8266896 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD ALLEGES FRICTION AND WEAR, LARGE AMOUNTS OF TOXIC COBALT AND CHROMIUM METAL IONS, PAIN, DISCOMFORT, FUNCTIONAL DIFFICULTIES AND ELEVATED METAL LEVELS.

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

  MAUDE report 8266840 ↗
• InjuryJan 18, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  LITIGATION ALLEGES CUP LOOSENING. DOI: (B)(6) 2009; DOR: NOT REPORTED; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Injury; Test Result; Tissue Damage

  MAUDE report 8261901 ↗
• InjuryJan 18, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES LOOSENING OF CUP, METAL WEAR, AND METALLOSIS.DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage

  MAUDE report 8260189 ↗
• InjuryJan 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES: IN 2002, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM IMPLANT IN HER RIGHT HIP. PATIENT SUFFERED DEBILITATING PAIN, SWELLING, INFLAMMATION, INFECTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. IN (B)(6) 2005, PATIENT WAS REVISED AND IMPLANTED WITH A NEW PINNACLE MOM DEVICE. IN 2010, THE NEW IMPLANT BEGAN SLIPPING OUT OF THE SOCKET CAUSING INTENSE PAIN, DISCOMFORT, AND THE INABILITY TO WALK WITHOUT ASSISTANCE. PATIENT IS UNABLE TO BE REVISED A SECOND TIME DUE TO TOO LITTLE BONE STRUCTURE REMAINING. DOI: 2002 - DOR: (B)(4) 2005 (RIGHT HIP; FIRST IMPLANTATION); DOI: (B)(6) 2005 - DOR: NONE (RIGHT HIP; SECOND IMPLANTATION). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 11/15/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ORIGINALLY IMPLANTED (B)(6) 2002 REVISED (B)(6) 2005 BECAUSE OF INSTABILITY. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 27 JUNE 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT

  Patient problems: Discomfort; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 8243931 ↗
• InjuryApr 13, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012 VIA THA. AFTER 6 YEARS FROM THE PRIMARY SURGERY, THE SURGEON NOTICED THE PROMINENT OSTEOLYSIS WAS OCCURRED AT THE ACETABULAR AND THE PROXIMAL TO THE FEMUR. ALSO, THE PATIENT COMPLAINED THE PAIN DUE TO THE LOOSENING, SO THAT THE SURGEON EXPLANTED THE IMPLANTS ON (B)(6) 2018. AFTER THE EXPLANTING SURGERY, THE SURGEON APPLIED THE CEMENT BEAD TREATMENT TO THE PATIENT WITH THE CEMENT CONTAINING VANCOMYCIN AFTER WASHING WITH POVIDONE IODINE SOLUTION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2012; DOR: (B)(6) 2018; UNKNOWN AFFECTED HIP.

  Patient problems: Not Applicable; Osteolysis; Pain

  MAUDE report 7428759 ↗
• InjuryFeb 1, 2018Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE PINNACLE CUP WITH METAL ON METAL ARTICULATION AT BONE TO CEMENT INTERFACE. THE SURGEON REMOVED AND REVISED THE CUP TO A COMPETITIVE PRODUCT. THE STEM WAS WELL FIXED AND RETAINED. THE SURGEON CHANGED THE HEAD TO A TS CERAMIC HEAD. LASTLY, THE SURGEON CANNOT PROVIDE THE ORIGINAL DATE OF IMPLANTATION. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7233701 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PPF ALLEGES PSEUDOTUMOR, METALLOSIS AND ELEVATED METAL IONS. ADDED DATE OF BIRTH OF PATIENT, PRODUCT DETAILS OF CUP, HEAD, LINER, STEM AND SCREWS IN IMPACTED PRODUCTS. DOI: ON (B)(6) 2010, DOR: ON (B)(6) 2017, LEFT HIP. CN (WIPRO).

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Pain

  MAUDE report 7107629 ↗