PINNACLE POROCOAT 1217-22-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295009870), received between Sep 15, 2017 and Oct 10, 2024 — classified as 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO SURGICAL DELAY, B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? - AFFECTED SIDE WAS LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 20422730 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  METAL ON METAL HIP MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT THA WITH METALLOSIS AND PSEUDOTUMOR RESULTING TO HIP PAIN AND ELEVATED METAL IONS. MRI CONFIRMED PSEUDOTUMOR. SLIGHT ELEVATED CELL COUNTS AND SED RATE. ASPIRATION CONFIRMED INFECTION. OPERATIVE NOTE REPORTED SCARRED EXTERNAL ROTATOR AND PURULENT APPEARING FLUID OBVIOUS BROWNISH PSEUDOTUMOR. THERE WAS CORROSION ON THE TRUNNION HOWEVER, STEM WAS WELL FIXED. THERE WAS 2 SCREWS 1 EASILY REMOVE AND THE OTHER ONE IS VERY DIFFICULT TO REMOVE. THERE WAS ACETABULAR MEMBRANE IN THE LINER AND SOME SMALL CAVITARY DEFECTS. DOI: (B)(6) 2007; DOR: (B)(6) 2023; RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17396223 ↗
• InjuryJun 16, 2023Migration; Migration

  IT WAS REPORTED THAT AS PER SURGEON, CUP WAS SPUN OUT. SURGEON REMOVED HEAD, LINER, SHELL. REAMED ACET AND PUT NEW CUP, LINER, SCREWS IN AND PUT NEW HEAD ON EXISTING STEM 157001135 (B)(4) ACTIVITY LEVEL - YES. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17143587 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW PATIENT WAS REVISED BASED ON THE PATHOLOGIC STUDY RESULTS: EXCISION OF BLOOD CLOT, PRE-OP DIAGNOSIS : INFECTION/INFLAMMATION; METALLIC GRAY FEMORAL STEM; METALLIC GRAY ACETABULAR CUP; A METALLIC FEMORAL BALL.

  Patient problems: Anxiety; Cyst(s); Depression; Distress; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Necrosis; Osteolysis; Pain; Pocket Erosion; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16902011 ↗
• InjuryNov 29, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO THE LOOSENING OF CUP CAUSING HIP PAIN. THE LOOSENING INTERFACE IS BONE TO IMPLANT. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15876600 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SUSPECTED INFECTION. SURGEON REPORTED SUMMIT FEMORAL STEM AND PINNACLE CUP WAS WELL FIXED. SURGEON ALSO REPORTED PATIENT HAD DONE WELL POST TOTAL HIP REPLACEMENT PRIOR TO A FALL WHICH HAD CAUSED A PERIPROSTHETIC FRACTURE. THE FRACTURE WAS TREATED WITH A STRYKER TROCHANTERIC HOOK PLATE AND HEALED BUT SUBSEQUENTLY BECAME INFECTED. THE HOOK PLATE WAS REMOVED AND THE INFECTION TREATED BUT NOT RESOLVED.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 13712112 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS RECEIVED. AFTER REVIEW OF RECORDS, LITIGATION ALLEGES THAT PATIENT CONTINUES TO SUFFER ECONOMIC, DAMAGES, SEVERE AND POSSIBLY PERMANENT INJURIES, PAIN, SUFFERING AND EMOTIONAL DISTRESS. (B)(6) 2007 (CUP AND STEM), (B)(6) 2020 (HEAD AND LINER), NONE REPORT, LEFT HIP. THIS COMPLAINT IS LINKED TO: (B)(4) - RIGHT HIP 1ST REVISION, (B)(4) - LEFT HIP 1ST REVISION, (B)(4) - ALLEGATION AFTER 1ST REVISION OF RIGHT HIP.

  Patient problems: Distress; Pain

  MAUDE report 13025230 ↗
• InjuryOct 5, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 12578560 ↗
• InjuryOct 4, 2021Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY. AFFECTED SIDE WAS THE LEFT HIP.

  Patient problems: Fall; Foreign Body Reaction; Joint Laxity

  MAUDE report 12570570 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR RE-REVISION. INFORMATION RECEIVED FROM CRAWFORDS. ASR REVISED (B)(6) 2012. REVISED TO PINNACLE CERAMIC. PINNACLE CERAMIC PRODUCTS REVISED DUE TO DISLOCATION (NOT ARISING FROM TRAUMATIC EVENT). HIP(S) TO BE REVISED: LEFT DOI: (B)(6) 2012 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: No Code Available

  MAUDE report 10514753 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED AND CLAIM LETTER RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC JOINT INFECTION STATUS POST MODULAR REVISION RIGHT THR. THERE WAS A LARGE VOLUME OF BLOOD TINGED MINIMALLY CLOUDY SEROUS FLUID. TISSUE WAS INFLAMED. LINER AND HEAD WERE REMOVED. PATIENT HAD A MINOR LEG LENGTH DISCREPANCY. CLAIM LETTER ALLEGES PAIN, DISCOMFORT AND LACK OF MOBILITY FROM THE AFFECTED HIP. DOI: (B)(6) 2019. DOR: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Discomfort; Edema; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Unspecified Infection

  MAUDE report 10260635 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAINFUL ASEPTIC FAILURE OF THE PATIENT'S RIGHT TOTAL HIP ARTHROPLASTY. THERE WAS PRESENCE OF THICK, FIBROTIC, REACTIVE TISSUE, FLUID WITHIN THE JOINT, PERIARTICULAR EROSIONS AND STRESS SHIELDING BEHIND THE SHELL. DOI: (B)(6) 2010 - DOR: (B)(6) 2017; (RIGHT HIP).

  Patient problems: Adhesion(s); Edema; Local Reaction; No Code Available; Pain; Pocket Erosion

  MAUDE report 9825840 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS DISCOMFORT. UPDATE AD 20 AUG 2018: (B)(4) IS REOPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE LITIGATION. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES INJURY, PAIN, LOSS OF MOBILITY, LOSS OF RANGE OF MOTION, MENTAL ANGUISH, EMOTIONAL DISTRESS, CORROSION AND FRICTION WEAR CAUSE TOXIC COBALT-CHROMIUM METAL DEBRIS TO BE RELEASED IN THE BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. ADDED STEM FROM INVOICE SEARCH DUE TO ALLEGED METAL IONS. LAW FIRM AND LAWYER. THE PATIENT HARMS AND DOI HAS BEEN UPDATED AS WELL. THE PRODUCT DETAILS FOR THE HEAD WAS CAPTURED ON INVOICE SEARCH AND HAS BEEN UPDATED. DOI: (B)(6) 2007; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Anxiety; Discomfort; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; Myocardial Infarction; No Code Available; Pain; Stroke/CVA

  MAUDE report 9750026 ↗
• InjuryJan 30, 2020Corroded; Corroded

  UNF AND MEDICAL RECORDS RECEIVED. THERE WERE NO NEW ALLEGATION REPORTED FROM UNF. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT TOTAL HIP REPLACEMENT WITH METALLOSIS, AND HIGH COBALT AND CHROMIUM LEVELS. REVISION NOTE REPORTED DISCOMFORT, INCREASE COBALT AND CHROMIUM LEVELS, AND ACETABULAR CUP SHOWED DISCOLORATION AND ACETABULAR COMPONENT WAS SIGNIFICANTLY CORRODED, AND IT WAS MENTION THAT THERE WERE NO METALLOSIS NOTED, AND NO SIGNS OF LYSIS AROUND STEM. DOI: (B)(6) 2009; DOR: (B)(6) 2019 (LEFT HIP) FIRST REVISION. PATIENT IS BILATERAL, PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 9647494 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO PAIN AND ELEVATED METAL IONS. DOI: 2008; DOR: (B)(6) 2019 RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9564628 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS ELEVATED METAL ION LEVELS PER THE DOCTOR THAT HAVE CONTINUED TO ELEVATE, AND ALSO HAD GROIN PAIN. THERE WAS CORROSION AT THE HEAD NECK JOINT. THERE WAS ALSO SOME FIBUROUS TISSUE INSIDE THE CUP AFTER THE LINER WAS REMOVED. PATIENT WAS VERY DIFFICULT TO DISLOCATE. LINER WAS REMOVED AND HEAD WAS REMOVED. POLY LINER WAS IMPLANTED WITH A NEW TS CERAMIC HEAD. DOI: (B)(6) 2007; DOR: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Adhesion(s); No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 9546622 ↗
• InjuryDec 12, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED SEVERE PAIN. ADDITIONALLY, IT IS ALLEGED THAT TOXIC AMOUNTS OF COBALT AND CHROMIUM ARE MAKING THEIR WAY INTO PATIENT'S HIP JOINT AND BLOOD STREAM. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED FAILED PAINFUL RIGHT METAL ON METAL TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES INDICATED MILDLY NECROTIC TISSUE, UNDERBELLY OF THE MUSCLE, ALL METALLIC-STAINED TISSUE, DAMAGE TISSUE AND SYNOVALIZED METAL-STAINED TISSUE REMOVED WITH BOVIE ELECTROCAUTERY. THE TRUNNION ITSELF APPEARED PRISTINE WITH DAMAGE TO THE POSTERIOR SIDE F THE NECK. THE ANTEVERSION OF THE STEM APPEARED TO BE 10-15 DEGREES. THE ACETABULAR COMPONENT IS ANTEVERTED AND SLIGHTLY VERTICAL. DOI: (B)(6) 2007; DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Necrosis; No Code Available; Pain; Tissue Damage

  MAUDE report 9458137 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM. DOI: (B)(6) 2007 - DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8517810 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT. UPDATE AD 13 JUL 2018. (B)(4) WAS RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION, METAL WEAR, METALLOSIS AND LOOSENING OF THE CUP. STEM, CUP AND SCREW HAS BEEN ADDED TO THE COMPLAINT AND PRODUCT DETAILS WERE PROVIDED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP, TOTAL HIP ARTHROPLASTY AND PSOAS TENDONITIS.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8424427 ↗
• InjuryFeb 13, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  LITIGATION ALLEGES LOOSENING. DOI: (B)(6) 2002 - DOR: (B)(6) 2006 (UNKNOWN HIP).

  Patient problems: Inadequate Osseointegration; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8335564 ↗
• InjuryFeb 8, 2019Use of Device Problem; Use of Device Problem

  PPF ALLEGES METAL WEAR. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED DUE TO FAILED LEFT TOTAL HIP REPLACEMENT-ADVERSE REACTION TO METAL.

  Patient problems: Inflammation; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8323802 ↗
• InjuryJan 22, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF CUP BEFORE FIRST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8266992 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THAT PATIENT EXPERIENCED SEVERE AND CONSTANT PAIN AND SUFFERING, SWELLING, TISSUE DAMAGE, SYNOVIAL FLUID BUILDUP, METALLOSIS AND/OR LACK OF MOBILITY. DOI: (B)(6) 2008 - DOR: (B)(6) 2009 (UNK SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE AD 06 JUL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED PPF ALLEGES INFECTION. ADDED AGE, LAWYER, SURGEON, UPDATED AFFECTED SIDE AND UPDATED PRODUCT DETAILS. ADDED STEM, SLEEVE, CUP AND SCREWS DUE TO ALLEGED INFECTION. CORRECTED DOI. DOI: (B)(6) 2008 - DOR: (B)(6) 2009 (LEFT HIP).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8264019 ↗
• InjuryJan 17, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT, STIFFNESS IN THE HIPS, AND DIFFICULTY WALKING. PPF ALLEGES STROKE/HEART ATTACK, PULMONARY EMBOLISM, LOOSENING OF CUP, LOOSENING OF STEM AND METAL WEAR/METALLOSIS. DOI: (B)(6) 2002; DOR: (B)(6) 2007; (LEFT HIP).

  Patient problems: Cardiac Arrest; Discomfort; Inadequate Osseointegration; Infarction, Cerebral; No Code Available; Pain; Pulmonary Embolism; Tissue Damage

  MAUDE report 8256778 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS TOXIC COBALT CHROMIUM METAL IONS, PAIN, DISCOMFORT, AND INFLAMMATION. PFS NOW ALLEGES POPPING, CLICKING, AND GRINDING. IT SHOULD BE NOTED THAT THE DOI OF (B)(6) 2005 IS A REVISION FROM A PREVIOUSLY HIP REPLACEMENT. NO DEPUY PRODUCTS WERE INVOLVED. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. NEW PPF ALLEGES INFECTION, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2005 - DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8231466 ↗