PINNACLE POROCOAT 1217-03-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295008668), received between Sep 26, 2017 and Dec 27, 2024 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION AND PAIN. AT REVISION THERE WAS CORROSION IN THE BORE OF THE FEMORAL HEAD.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21026543 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE CUP, LINER AND STEM WERE ALL REMOVED AND REPLACED WITH PROSTALAC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20257994 ↗
• InjuryApr 10, 2023Difficult to Remove; Difficult to Remove

  PATIENT WAS REVISED DUE TO PAIN, STEM WAS REMOVED THOUGHT IT WAS LOOSE BUT IT WAS NOT REMOVED ANYWAY , CUP HAD A METAL ON METAL LINE COULD NOT GET LINER TO DISENGAGE SO TOOK THE CUP. DOI: UNKNOWN. DOR: (B)(6) 2023 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16707436 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ALLEGES SIGNIFICANT PAIN, INJURY CAUSED BY METALLOSIS, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, AND LIMITATION OF DAILY ACTIVITIES. DAMAGES WERE DUE TO THE DEFECTS AND UNREASONABLE DANGER FROM THE SYSTEM. MOREOVER, PATIENT SUFFERED INJURY TO HIS MUSCLE AND TISSUE, ADDITIONAL SCAR TISSUE FORMATION, PSEUDOTUMOR EXCISION AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY. IN ADDITION, PATIENT INCURRED LOST EARNING POTENTIAL. EXPERIENCED AND SUFFERED MENTAL PAIN, EMOTIONAL TRAUMA AND DISTRESS AND IS LIKELY TO SUFFER CONTINUED BOTH INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING, PHYSICAL DISABILITY AND PAST PRESENT AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE AND PHARMACEUTICAL EXPENSES AND OTHER RELATED DAMAGES. DOI: (B)(6) 2010 DOE/DOR: (B)(6) 2022 AFFECTED SIDE.

  Patient problems: Cyst(s); Distress; Fibrosis; Foreign Body Reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15889678 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Pain

  MAUDE report 12229333 ↗
• InjuryMay 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE POLY DISASSOCIATED FROM THE CUP. INSERTED A NEW POLY WITH NO ISSUES WITH LOCKING MECHANISM. POLY WAS LOCKED AND STABLE. DOI: (B)(6) 2010. DOR: (B)(6) 2021. RIGHT HIP.

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

  MAUDE report 11805374 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, EMOTIONAL DISTRESS, DISFIGUREMENT AND INJURIES. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS, WHILE PFS ALLEGES NUMBNESS, STIFFNESS, INSTABILITY, WEAKNESS, LIMITED ROM, SOFT TISSUE DESTRUCTION AND ANXIETY. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO FAILED RIGHT THA, WITH METALLOSIS AND SOFT TISSUE DESTRUCTION. OPERATIVE NOTES REPORTED THAT UPON ENTERING HE INTRA-ARTICULAR SPACES, METALLOSIS DEBRIS WAS EXPELLED AND THERE WAS EVIDENT OF SOME METAL STAINING OF THE SOFT TISSUE. THERE WAS SOME TRUNNION CORROSION AND DEBRIS, BUT THE TRUNNION LOOKED INTACT. THE FEMUR WAS 5-10 DEGREES ANTERVERSION. TTE LINER HAS SOME OLD STAINING BEHIND IT, INCLUDING SOME METALLOSIS AND CORROSION. ADDED STEM AND CUP TO THE COMPLAINT. PRODUCT AND LOT NUMBERS WERE PROVIDED. ADDED SURGEON, MEDICAL HISTORY, PATIENT DOB, AGE, HEIGHT AND WEIGHT. DOI: (B)(6) 2010; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Foreign Body Reaction; Hypoesthesia; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage; Weakness

  MAUDE report 9610979 ↗
• InjuryJan 9, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS PAIN AND CONCERN OF CHROMIUM LEVELS FOR PATIENT. UPDATE 27 MAR 2019 (B)(4) HAS BEEN RE-OPENED DUE TO RECEIPT OF PCF AND MEDICAL RECORDS. PCF HAS NO NEW ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESSED FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METALLOSIS AND ADVERSE LOCAL TISSUE REACTION. THERE IS BLACKISH DEBRIS AT THE INTERFACE BETWEEN THE METAL LINER AND THE ACETABULAR COMPONENT AND A BLACKISH MATERIAL WITHIN THE MORSE TAPER OF THE HIP BALL AND ON THE TRUNNION OF THE STEM. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9568881 ↗
• InjuryAug 9, 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. THE STEM IS BEING ADDED FOR THE COMPLAINT FOR THE ALLEGED HIGH METAL IONS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGED LOOSENING OF THE CUP. THE PRODUCT EXPERIENCE CODE, PATIENT HARM, UNKNOWN LINER, UNKNOWN HEAD, AND THE UNKNOWN STEM WERE UPDATED. THE CUP WAS ADDED TO THE IMPACTED PRODUCT DUE TO THE ALLEGED LOOSENING. DOI: (B)(6) 2002. DOI: (B)(6) 2007. (RIGHT HIP) FIRST REVISION.

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

  MAUDE report 8879044 ↗
• InjuryMay 3, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT FELL CAUSING THE CUP TO SPIN OUT. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8578069 ↗
• MalfunctionMay 1, 2019Difficult to Insert; Difficult to Insert

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT DURING PRIMARY SURGERY, AS THE SURGEON WAS ATTEMPTING TO PUT IN THE INITIAL PINNACLE LINER, IT WAS FELT TO BE JAMMED. THE SURGEON THEN ELECTED TO NOT USE THE PINNACLE IMPLANTS AND INSTEAD SWITCHED TO ASR IMPLANTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570027 ↗
• InjuryApr 15, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES PAIN, DISCOMFORT, IMMOBILITY, INFLAMMATION AND HIGH LEVELS OF CHROMIUM AND COBALT. UPDATE: PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR AND LOOSENING OF CUP. DOI: (B)(6) 2004; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Tissue Damage

  MAUDE report 8515016 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PFS ALLEGES VERY HIGH CHROMIUM AND COBALT LEVELS IN THE BLOOD, MASSIVE INFECTION ((B)(6) AND GROUP B STREP), AND RENAL FAILURE DUE TO ANTIBIOTIC THERAPY. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS EFFUSION. REVISION NOTE STATED THAT THERE WAS EFFUSION, EXUBERANT SYNOVITIS, AND THE TISSUE LOOKED VIABLE BUT DID NOT APPEAR TO HAVE INFECTION. CBC SHOWED ELEVATED WBC AND NEUTROPHILS COUNT.

  Patient problems: Bone Fracture(s); No Code Available; Synovitis

  MAUDE report 8482311 ↗
• InjuryMar 1, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  UPDATE AD 10 JUL 2018: RECEIPT OF PPF AND IMPLANT RECORDS. PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS BEFORE FIRST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available; Tissue Damage

  MAUDE report 8381573 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN AND FEELINGS OF SUBLUXATION (RIGHT SIDE). UPDATE 01/19/2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. DOI: (B)(6) 2006. UPDATE 12/19/2014- PFS NOW ALLEGES HIGH METAL IONS AND METALLOSIS. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED SUBLUXATION DUE TO SOFT TISSUE LAXITY AND METAL REACTION. ONLY THE FEMORAL HEAD WAS REVISED. ALL LABS RESULTS FOR METAL IONS WERE AFTER THE DOR, THE STEM IS BEING ADDED FOR THE ALLEGED HIGH METAL IONS. THERE WAS NO MENTION OF METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE AD 20 JUN 2018 RECEIPT OF PPF AND IMPLANT RECORDS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGES STROKE AND HEART ATTACK BEFORE FIRST REVISION. ADDED CUP TO ADDRESS STROKE AND HEART ATTACK.

  Patient problems: Cardiac Arrest; Infarction, Cerebral; No Code Available; Pain

  MAUDE report 8373348 ↗
• InjuryFeb 27, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LOOSENING OF CUP. .

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8373312 ↗
• InjuryFeb 8, 2019Loose or Intermittent Connection; Osseointegration Problem; Loose or Intermittent Connection; Osseointegration Problem

  CORRECTED PATIENT HARM. SOFT TISSUE INJURY WAS CHANGED TO FOREIGN BODY REACTION.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Loss of Range of Motion; No Code Available; Pain; Tissue Damage

  MAUDE report 8320780 ↗
• InjuryJan 23, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD MOM IMPLANT AND LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. THE SURGEON NOTED THE HIP HAD BLACK DEBRIS WITHIN THE HIP JOINT. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8270354 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  PATIENT REPORTED WITH PAINFUL LEFT TOTAL HIP ARTHROPLASTY (54 PINNACLE 300, 36X54 ULTIMET LINER, 36 +5 COBALT CHROME HEAD, AND AML STEM). INITIAL PLAN WAS TO REVISE METAL LINER TO POLY AND RETAIN CUP. EXPOSURE REVEALED MALE ALIGNED CUP; THEREFORE, DETERMINATION MADE TO REVISE ENTIRE CUP, LINER AND HEAD CONSTRUCT. REVISED TO A 58 PINNACLE MULTIHOLE, ALTRX 40X58 +410 LINER, AND +5 DELTA CERAMIC HEAD RESULTING IN A STABLE CONSTRUCT. APPARENT CORROSION AT THE HEAD GRUNION INTERFACE. NO CORROSION NOTED AT CUP/LINER INTERFACE AS THE METAL LINER WAS APPARENTLY MAL-ALIGNED AND INCARCERATED IN THE CUP LIKELY DUE TO ERROR IN PLACING THE IMPLANT DURING THE INDEX PROCEDURE.

  Patient problems: No Code Available; Pain

  MAUDE report 8261943 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION, LOOSENING OF STEM, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2011 - DOR: (B)(6) 2013 (RIGHT HIP).

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

  MAUDE report 8243650 ↗
• InjuryJan 10, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENTS ACETABULAR CUP WAS REMOVED AND REPLACED WITH A 58 MULTIHOLE CUP AND 58 + 4 10 DEGREE 40MM LINER DUE TO PRIOR DISLOCATION. DOI: (B)(6) 2016, DOR: DEC. 13, 2018, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8235370 ↗
• InjuryDec 5, 2018Loss of or Failure to Bond; Loss of Osseointegration; Loss of or Failure to Bond; Loss of Osseointegration

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS EXTREMELY HIGH ION LEVELS. DOI: (B)(6) 2007 - DOR: (B)(6) 2011 (RIGHT HIP). UPDATE: 10/17/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 06 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO PPF AND STICKER SHEET RECORD RECEIVED. PPF ALLEGES LOOSENING OF CUP AND ELEVATED METAL IONS. ADDED LAWYER NAME, LAW FIRM NAME, EXPIRATION DATE, UDI AND PATIENT HARM. ADDED CUP IN THE IP RECORDS DUE TO LOOSENING OF THE CUP HOWEVER, IT WAS NOT REVISED. CORRECTED MANUFACTURING DATE HEAD, LINER AND REVISION HOSPITAL. DOI: (B)(6) 2007: DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8134258 ↗
• InjuryNov 14, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES INFECTION AND LOOSENING OF THE STEM.

  Patient problems: Unspecified Infection

  MAUDE report 8070348 ↗
• InjuryAug 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2014; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7818612 ↗
• InjuryApr 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT'S INFECTED REVISION HIP WAS REMOVED AND THEN REPLACED WITH A PROSTALAC HIP UNTIL THE INFECTION IS CLEAR. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7435820 ↗