PINNACLE POROCOAT 1217-03-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295008682), received between Jul 11, 2017 and Dec 9, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT HIP WAS REPLACED 15 YRS AGO AT A DIFFERENT HOSPITAL; THE EXACT DATE IS NOT KNOWN. X-RAYS SHOW THE LEFT HIP PARTIALLY SUBLUXED SUPERIOR AND LATERALLY. IT WAS DISCOVERED AFTER DISLOCATION THAT THE POLY LINER HAD ROTATED IN THE CUP TO A POSITION THAT ALLOWED THE FEMORAL HEAD TO ARTICULATED AGAINST THE INSIDE SUPERIOR PORTION OF THE ACETABULAR CUP GENERATING A FAIR AMOUNT OF TITANIUM WEAR DEBRIS. THE DEBRIS WAS IRRIGATED FROM THE HIP AREA. FOUR OF THE SIX ARD'S ON THE POLY LINER HAD BEEN SHEARED OFF. THERE WAS LOOSENING OF ACETABULAR LINER AT BONE TO IMPLANT INTERFACE. THE CONDITION OF THE CUP WAS ASSESSED AND FOUND TO BE ADEQUATE FOR CONTINUED USE. AN ALTRX LINER, 36MM X 58MM +4 10° WAS IMPACTED IN THE CUP AND A NEW FEMORAL HEAD WAS IMPACTED ON THE AML TRUNION. NO OTHER IMPLANTS WERE REMOVED/REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 23757496 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, PFS AND MEDICAL RECORDS RECEIVED. PPF HAS NO ALLEGATION. PFS ALLEGES PAIN, GAIN WEIGHT, DM, HEART ISSUES, WALKING DIFFICULTY, DECREASE ROM, METALLOSIS AND PATIENT SUSPECT METAL IN BLOOD CAUSED MEMORY IMPAIRMENT. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION WAS SCHEDULED DUE TO DIABETES AND HEART CONDITION AS WELL AS THROAT ISSUE, PATIENT COULD NOT BE INTUBATED AND THAT A REVISION SURGERY WOULD BE OUT OF THE QUESTION. PATIENT ALSO REPORTED CONCERNS ABOUT METALLOSIS. DOI: (B)(6) 2008, DOR: NONE REPORTED, LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrial Fibrillation; Foreign Body Reaction; Ischemic Heart Disease; Loss of Range of Motion; Pain; Pericardial Effusion

  MAUDE report 11660987 ↗
• InjuryMar 22, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED HIP, WHICH HAPPENED TO BE METAL ON METAL, SURGEON CONDUCTED AN I&D AND REPLACED LINER AND HEAD. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAIN AND INFECTION. OPERATIVE NOTES FINDINGS OF GROSS LEFT HIP PURULENCE TRACKED JUST DISTAL AND ANTERIOR TO THE GLUTEAL SLING, ALONG THE CALCAR WHERE THERE WAS SOME BONE LOSS AND UP THE ILIOPSOAS BURSA. EVIDENCE OF METALLOSIS STAINING AT AREAS IN THE SYNOVIUM. THERE WAS METAL DEBRIS BEHIND THE LINER. SIGNIFICANT AMOUNT OF OVERHANGING BONE ANTERIOR AND SUPERIOR WITH THE CUP AND VERY LITTLE ANTEVERSION. DOI: (B)(6) 2006. DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain

  MAUDE report 11541018 ↗
• InjuryDec 16, 2020Use of Device Problem; Use of Device Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR UNSTABLE LEFT THR DUE TO A COMBINATION OF SOFT TISSUE/MUSCULAR DAMAGE FROM PREVIOUS METALLOSIS, POSTERIOR IMPINGEMENT ON THE HOODED POLYETHYLENE INSERT, AND EXCESSIVE ANTEVERSION AND VERTICALITY OF HIS ACETABULAR CUP THAT HAD BEEN IMPLANTED IN 2005. THE PATIENT ALSO DEVELOP ANTERIOR RECURRENT DISLOCATION. OPERATIVE NOTES REPORTED THAT THERE WERE NO EXTERNAL ROTATOR OR POSTERIOR CAPSULE PRESENT DUE TO PREVIOUS SOFT DAMAGE ASSOCIATED WITH HIS METALLOSIS. THE PATIENT WAS IMPINGING POSTERIORLY VIA THE POSTERIOR GREATER TROCHANTER ON THE 10 DEGREE HOOD POLY INSERT. POSITIONING OF THE CUP WAS CONFIRMED TO BE SLIGHTLY VERTICAL AND ANTEVERTED FROM IDEAL. DOI: (B)(6) 2005 (CUP), DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11020298 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES INFECTION AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT DEVELOPED BACTEREMIA AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS THEN REVISED FOR DEEP INFECTION STATUS POST REVISION RIGHT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES REPORTED THAT THERE WERE MODERATE AMOUNT OF PURULENT MATERIAL IMMEDIATELY BELOW THE SURFACE OF THE SKIN AND A LARGE AMOUNT OF PURULENT MATERIAL ARISING FROM THE HIP JOINT AND EXTENDING DISTALLY. THERE WAS A SIGNIFICANT OSTEOLYSIS OF THE GREATER TROCHANTER WITH A PATHOLOGIC FRACTURE THROUGH THE GREATER TROCHANTER RELATED TO OSTEOLYSIS. STEM AND HEAD WERE NON-DEPUY PRODUCT. DOI: (B)(6) 2017. DOR: (B)(6) 2017; RIGHT HIP. (B)(4) 1ST REVISION.

  Patient problems: Necrosis; No Code Available; Osteolysis; Swelling; Unspecified Infection

  MAUDE report 9928596 ↗
• InjurySep 9, 2019Loss of or Failure to Bond; Loss of Osseointegration; Loss of or Failure to Bond; Loss of Osseointegration

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD, TISSUE, AND BONE. RECORDS INDICATE THAT THE REVISION FOR THE RIGHT SIDE WAS DUE TO ACETABULAR LOOSENING. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METALLOSIS AND LOOSENING OF THE CUP. AFTER REVIEW OF MEDICAL RECORDS, MEDICAL RECORDS REPORTED PAIN, LIMITATIONS ON THE LEFT HIP AND REDUCED RANGE OF MOTION. THERE WAS NO REVISION REPORTED. COBALT-CHROMIUM LEVEL IS BELOW 7 PPB. DOI: (B)(6) 2008, DOR: NOT REVISED, (LEFT HIP). PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Inadequate Osseointegration; Inflammation; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Pain

  MAUDE report 8977285 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PERSISTENT PAIN AND A POPPING SENSATION IN HIP. UPDATE (B)(6) 2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED (B)(6) 2013. THE REPORT STATES THAT THE PATIENT WAS ASYMPTOMATIC, BUT FAMILY, DUE TO NEGATIVE PRESS, WANTED HIS METAL LINER SWAPPED OUT FOR A POLY LINER. ALSO, PATIENT'S ATTORNEY INSISTS THE HIS IS ASR; HOWEVER, ALL DOCUMENTATION PROVES OTHERWISE. UPDATE 12/19/2014- PFS AND MEDICAL RECORDS RECEIVED. PFS NOW ALLEGES HIGH METAL IONS AND METALLOSIS. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED HIGH METAL IONS (LAB RESULTS FROM (B)(6) 2011) SUPPORT THIS. THE STEM IS BEING ADDED FOR THE HIGH METAL IONS. THERE WAS NO MENTION OF METALLOSIS. 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 8349740 ↗
• InjuryJan 25, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD BEEN HAPPY WITH HIS HIP "UNTLL" RECENTLY HE PRESENTED AT (B)(6) WITH PAIN. THE X RAY SHOWED A WORN TAPER HEAD JUNCTION. AFTER INITIAL CONSULTATION THE PATIENT WAS LISTED FOR REVISION SURGERY. UNFORTUNATELY THIS HAD TO BE BROUGHT FORWARD AS THE TAPER APPEARED TO WEAR OUT VERY QUICKLY AND SO DISASSOCIATED FROM THE HEAD LEAVING A SHARP TAPER AND MOM DEBRIS IN THE JOINT SPACE. UPON REVISION MOM DEBRIS WAS SEEN AND THE HIP "DEBRIED" SUCCESSFULLY. THE CEMENTED ELITE PLUS STEM PULLED OUT FROM FEMUR WITH EASE. THE CUP WAS ALSO REMOVED AND REVISION IMPLANTS USED TO CORRECT THE DEFORMITY. AN ETO WAS USED TO ACCESS THE FEMUR AND REMOVE THE CEMENT.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8277859 ↗
• InjuryNov 28, 2018Loose or Intermittent Connection; Loss of Osseointegration; Loose or Intermittent Connection; Loss of Osseointegration

  LITIGATION ALLEGES PSEUDOTUMOR AND LOOSENING. DOI: (B)(6) 2005 - DOR: (B)(6) 2007 (RIGHT HIP).

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

  MAUDE report 8109971 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES DISLOCATION (OPEN & CLOSED) REDUCTION AND INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8089146 ↗
• InjuryJul 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6702198 ↗