PINNACLE POROCOAT 1217-01-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295008590), received between Jul 21, 2017 and Nov 6, 2023 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• InjuryNov 6, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  INLAY LUXATION FROM THE CUP FOR NO APPARENT REASON. THIS RESULTED IN AN OPERATION ON (B)(6) 2023 WITH CHANGING THE CUP, INLAY AND HEAD.

  Patient problems: Pain

  MAUDE report 18072288 ↗
• InjuryFeb 11, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT STARTED REPORTED SUBLUXATION IN LEFT HIP IN 2017. DURING GARDENING WORK, SHE REPORTS EXPERIENCING MORE INTENSIVE SUBLUXATION WITH CREAKING. RADIOGRAPHIC DIAGNOSE WAS DECENTRALIZED HEAD DUE TO PE (LINER) FRACTURE OR LUXATION. REVISION WAS PERFORMED AND INTRAOPERATIVE FINDINGS INCLUDED GRANULOMA FROM ABRASION RESULTING IN DEBRIDEMENT AND HISTOLOGY. THE PE (LINER) LOCATED AT AN ANGLE IN THE CUP RESULTING IN CERAMIC HEAD ARTICULATING WITH METAL RIM OF CUP. CERAMIC HEAD NOTED AS SEVERELY DAMAGED FEATURING METAL GRINDING MARKS. CERAMIC HEAD WAS CAREFULLY CHIPPED OFF, CAREFUL REMOVAL OF CERAMIC PARTICLES AND EXTENSIVE DEBRIDEMENT WITH CAREFUL RINSING PERFORMED. NOTES INDICATE THE CONUS (TAPER) OF STEM HAS MINOR DAMAGE (NO FURTHER DETAILS PROVIDED) AND LEFT IN SITU. CERAMIC HEAD REPLACED WITH REVISION CERAMIC HEAD WITH METAL INNER SLEEVE AFTER CONUS HAD BEEN CLEANED. LINER WAS REPLACED WITH ANOTHER PE LINER. DOI: (B)(6) 2014. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 11313049 ↗
• InjuryMar 23, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS FAILED RIGHT TOTAL HIP REPLACEMENT. OPERATIVE NOTES REPORTED THAT AFTER EXCISION THERE WAS A LARGE BURSA PRESENTING ITSELF IN AN AREA OF AVULSION OF PREVISION REPAIR. THE CUP WAS 5 DEGREES ANTEVERSION. DOI: (B)(6) 2004. DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Inflammation; No Code Available

  MAUDE report 9868963 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD , PATIENT WAS REVISED TO ADDRESS FAILED METAL ON METAL RIGHT TOTAL HIP ARTHROPLASTY. REVISION NOTES STATED THAT METAL STAINING OF THE SYNOVIUM AND CAPSULE WAS ENCOUNTERED AND AN EXTENSIVE SYNOVECTOMY PERFORMED UNDER DIRECT VISION. HEAD, LINER, AND CUP WERE REMOVED. PATIENT HAD ELEVATED METAL ION. DURING IMPLANTATION, THE PATIENT'S SURGERY WAS SIGNIFICANT FOR EXCESSIVE BLOOD LOSS (2000 ML), REPLACED WITH 3.5L OF CRYSTALLOID, 900ML VIA THE CELL SAVER AND 1 UNIT OF AUTOLOGOUS BLOOD. DOI: (B)(6) 2008 - DOR: (B)(6) 2018 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 9842566 ↗
• InjuryFeb 14, 2020Corroded; Corroded

  THE PATIENT WAS REVISED DUE TO METALLOSIS. THE HEAD AND LINER WERE EXCHANGED. DOI: UNK; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Pain

  MAUDE report 9712991 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF REVISION: (B)(6) 2019; (RIGHT HIP). TREATMENT: ALL PRODUCTS EXPLANTED, REPLACED WITH AN ANTIBIOTIC SPACER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9613193 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND SWELLING (LEFT SIDE). DOI: (B)(6) 2003, DOR (B)(6) 2007. UPDATE AD 31 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO PINNACLE LITIGATION RECORD RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED. LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION AND DIFFICULTY AMBULATING, PERFORMING DAILY ACTIVITIES, SWELLING AND EMOTIONAL DISTRESS. ADDED REVISION SURGEON NAME, LAWYER NAME, UDI AND PATIENT HARM. CORRECTED MANUFACTURING DATE. DOI: (B)(6) 2003; DOR: (B)(6) 2007; LEFT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 9109745 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ LEGACY SYSTEM COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND ELEVATED LEVELS OF COBALT CHROMIUM METAL IONS AND PARTICLES IN THE BLOOD AND TISSUE SURROUNDING THE IMPLANT. DOI: (B)(6) 2003; - DOR: NONE REPORTED; ( RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 11/8/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PATIENT DEMOGRAPHICS ADDED.. UPDATE 2/24/16-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, A DOR WAS PROVIDED. THE REVISION OPERATIVE NOTE INDICATED METALLOSIS AND TRUNNIONOSIS. THE STEM IS BEING ADDED TO THE COMPLAINT. LAB RESULTS INDICATED THE METAL ION LEVELS WERE BELOW 7PPB. THE COMPLAINT WAS UPDATED ON: 3/14/2016. UPDATE AD 26 APRIL 2018: COM-(B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS.  IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFF ALLEGES METAL WEAR AND METALLOSIS CONFIRMED IN THE MEDICAL RECORDS. IT ALSO PROVIDED THE COMPLETE PATIENT DETAILS. UPDATED PAT

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; No Code Available; Pain

  MAUDE report 9008024 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES BONE FRACTURE. DOI: (B)(6) 2002; DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Bone Fracture(s); Discomfort; Inflammation; No Code Available; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8331548 ↗
• InjuryJan 3, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT SUFFERED FROM SEVERE PAIN AND DISCOMFORT, AND MECHANICAL LOOSENING. UPDATE 2/25/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS REPORTED HETEROTOPIC OSSIFICATION. UPDATE AD 03 MAY 2018 THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP AND STEM.

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

  MAUDE report 8212052 ↗
• InjuryOct 30, 2018Positioning Problem; Positioning Problem

  PINNACLE MODULAR METAL ON METAL WAS REVISED DUE TO PAIN AND HIGHER THAN NORMAL ION LEVELS.

  Patient problems: Necrosis; No Code Available; Pain; Tissue Damage

  MAUDE report 8018547 ↗
• InjuryAug 17, 2018Loss of Osseointegration; Loss of Osseointegration

  COMPLAINT DESCRIPTION: 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. UPDATE 8/17/2015-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THEY INDICATED ELEVATED METAL ION LEVELS (NO REVISION OPERATIVE NOTE INCLUDED). THE PART/LOT IS BEING UPDATED AND THE STEM IS BEING ADDED TO THE COMPLAINT. THE COMPLAINT WAS UPDATED ON: 9/11/2015. UPDATE AD 20 APR 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION IN WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, LOOSENING OF CUP, METAL WEAR, AND METALLOSIS. ADDED LAW FIRM. DOI: (B)(6) 2003 - DOR: (B)(6) 2013 (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Not Applicable; Pain; Tissue Damage

  MAUDE report 7793239 ↗
• InjuryJun 14, 2018Malposition of Device; Malposition of Device

  DER STATES METAL ON METAL WITH MALPOSITIONED CUP. DOI: (B)(6) 2006; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7600435 ↗
• InjuryDec 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND MEDICAL RECORDS RECEIVED.PPF ALLEGES INFECTION AFTER 1ST REVISION. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY,THERE IS NO REVISION NOTES REPORTED.

  Patient problems: Abscess; Fatigue; Fever; Unspecified Infection; Weakness

  MAUDE report 7084308 ↗
• InjurySep 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS RECURRING DISLOCATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 6868865 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MAY 03, 2017: LITIGATION RECEIVED. PFS ALLEGES SEVERE PAIN, DISLOCATION, DISCOMFORT, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT. IT WAS ALSO REPORTED THAT THE PATIENT HAD A REVISION ON (B)(6) 2010 AND (B)(6) 2011. IT IS UNKNOWN WHAT COMPONENTS WERE REMOVED DURING THE REVISION AND IT IS ALSO UNKNOWN IF DEPUY COMPONENTS WERE IMPLANTED. NO MEDICAL RECORDS AND LABORATORY VALUES PROVIDED. UPDATE JUN 22, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES SWELLING IN LEFT LEG. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED DUE TO DISLOCATED ANTIBIOTIC SPACER. REVISION NOTES STATED THAT THE WOUND RELEASED A SIGNIFICANT AMOUNT OF COLLECTED SERONSANGUINEOUS FLUID MIXED WITH BLOOD. THE ANTIBIOTIC SPACER WAS IMMEDIATELY APPARENT AND WAS REMOVED. IT WAS PREVIOUSLY REPORTED ON THE LITIGATION THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2010, AND ON (B)(6) 2011, HOWEVER ,THERE WERE NO MEDICAL RECORDS. SHALL THERE BE NEW INFORMATION RECEIVED

  Patient problems: Discomfort; Joint Dislocation; Pain; Unspecified Infection

  MAUDE report 6731772 ↗