PINNACLE POROCOAT 1217-01-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295008538), received between Nov 8, 2017 and Nov 6, 2025 — classified as 23 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  DURING A REVISION SURGERY OF A HIP PROSTHESIS, A THIN MEMBRANE-LIKE STRUCTURE WAS OBSERVED BETWEEN THE METAL COMPONENT AND THE PLASTIC LINER, SUSPECTED TO HAVE DETACHED FROM THE SURFACE OF THE METAL COMPONENT. HOWEVER, THIS REMAINED UNCERTAIN AS THE INNER SURFACE AND LOCKING MECHANISM OF THE METAL COMPONENT APPEARED INTACT UPON INSPECTION, AND THE COMPONENT WAS NOT REPLACED. THE PATIENT RECOVERED FROM THE SURGERY WITHOUT COMPLICATIONS. AT THE TIME OF SURGERY, THE FINDING WAS INTERPRETED AS A TYPICAL FRICTION-RELATED REACTION BETWEEN METAL PARTS, RESULTING IN A PSEUDOTUMOR. THE SUSPICION OF A FAULTY PROSTHESIS COMPONENT AROSE LATER WHEN AN EXTERNAL EXPERT REVIEWED THE MEDICAL RECORDS. THE PELVIC COMPONENT OF THE PROSTHESIS IS STILL IN USE, AND THE PATIENT HAS RECOVERED FROM THE REVISION SURGERY WITHOUT COMPLICATIONS.

  Patient problems: Hypersensitivity/Allergic reaction; Medical Device Site Inflammation; Pain

  MAUDE report 23490756 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER INFORMED US ABOUT AN EXPLANTATION OF AN UNKNOWN HIP IMPLANT. ADDITIONAL EVENT INFORMATION: REASON FOR REVISION WAS DUE TO INLAY WEAR WITH CONSECUTIVE DE-CENTERING OF THE FEMORAL HEAD. SURGERY TIME WAS PROLONGED DUE TO DISTINCT METALLOSIS. AFFECTED SIDE: LEFT.

  Patient problems: Foreign Body Reaction

  MAUDE report 19281655 ↗
• InjuryMar 21, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  (B)(6) 2021: PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT. (B)(6) 2023: PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO PAIN, FEELING OF SHIFTING, AND GRINDING/CREPITUS. X-RAYS SHOWED ANTERIOR SUBLUXATION OF THE FEMORAL HEAD. INTRA-OP THE POLYETHYLENE HAD DISASSOCIATED FROM THE SHELL AND HEAD WAS ABRADING ON THE ANTERIOR ASPECT OF THE ACETABULAR SHELL. POST-OP NOTE ALSO INDICATED THE POLYETHYLENE LINER WAS BROKEN. THE CUP, LINER AND FEMORAL HEAD WERE REVISED. DOI: (B)(6) 2021 DOR: (B)(6) 2023 AFFECTED SITE: RIGHT HIP.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 18954008 ↗
• InjuryJan 17, 2023Device Dislodged or Dislocated; Naturally Worn; Osseointegration Problem; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Osseointegration Problem; Noise, Audible

  MEDICAL RECORDS WERE RECEIVED AND STATED THE FOLLOWING: ON (B)(6)2018, THE PATIENT HAD A LEFT KNEE TEP TO ADDRESS ADVANCE GONARTHROSIS. IT WAS NOTED THAT THE PATIENT HAD OFE NEXGEN, LEFT 2, WHICH IS A COMPETITOR KNEE. ON (B)(6)2021 THE PATIENT HAD A RIGHT CEMENTED DEPUY SIGMA KNEE TEP WITH COMPETITOR CEMENT WAS USED. THERE IS A STICKER SHEET ON PAGE 153 OF 242 THAT SHOWS COMPETITOR COMPONENTS WERE IMPLANTED PATIENT¿S KNEE AT SOME POINT IN 2021. IT SHOULD BE NOTED THAT THERE WAS A LEFT FEMORAL COMPONENT, WHICH IS AT ODDS WITH THE DATES PROVIDED. ON (B)(6)2021 IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6)2021, THE PATIENT HAD A RIGHT KNEE JOINT MOBILIZATION UNDER ANESTHESIA TO ADDRESS ADHESIONS AND LIMITED RANGE OF MOTION. ON (B)(6)2022 THE PATIENT HAD A REVISION LEFT HIP. THE SURGEON REPORTED FINDING ASEPTIC PELVIC RELAXATION LEFT. INLAY LUXATION AND METALLOSIS. THERE SURGEON NOTED ABUNDANT GRANULATED TISSUE, THE ACETABULAR LINER HAD SIGNIFICANT DAMAGE AND WAS CAUDALLY LUXATED. THE ACETABULAR CUP HAD DAMAGE AND LOOSENING AND WAS REMOVED. THE ACETABULAR CUP, LINER AND FEMORAL HEAD WERE REVISED. ON (B)(6)2022 PA

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 16183376 ↗
• InjuryJan 13, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  SURGEON GAVE A CALL DIRECTLY TO COMPLAINT HANDLING UNIT: IMPLANTATION OF HIP-TEP RIGHT SIDE ON (B)(6) 2021. REVISION OF ACETABULAR COMPONENTS ON (B)(6) 2023 AS INLAY DISASSOCIATED FROM CUP. CUP WAS REVISED AS WELL AS IT WAS DAMAGED FROM CONTACT TO HIP-HEAD. DOI: (B)(6) 2021, DOR: (B)(6) 2023, RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Laxity

  MAUDE report 16156981 ↗
• InjurySep 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HCP REPORTED TO SALES REP AS WELL AS TO BFARM "REVISION OF LEFT HIP-TEP BECAUSE OF INLAY DISLOCATION. PRIMARY IMPLANTATION LESS THAN 2 YEARS AGO. PRIMARY IMPLANTATION DUE TO COXARTHROSIS. PRIMARY IMPLANTS: PINNACLE 100 CUP SIZE 48; CORAIL HIP STEM LAT. SIZE 9 CEMENTLESS WITHOUT COLLAR; MARATHON PE INLAY +4.10° INNER DIA 32 OUTER DIA 48MM; CERAMAX CERAMIC FEMORAL HEAD 32+5 MEDIUM. REVISION WITH HEAD AND INLAY CHANGE. LUXATION EVENT OCCURRED DURING PASSIVE ROTATIONAL MOVEMENT OF THE LOWER LEG."

  Patient problems: Insufficient Information

  MAUDE report 15438068 ↗
• InjurySep 12, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION OF ACETABULAR COMPONENTS OF A HIP-TEP UNKNOWN SIDE BECAUSE OF STRONG PE-WEAR. DOI: UNKNOWN, DOR: (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 15401452 ↗
• InjuryDec 21, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  MEDICAL RECORDS RECEIVED. ON MAY 15, 2018, THE PATIENT HAD INFILTRATION OF THE SACROILIAC JOINT RIGHT, TO ADDRESS ACUTE LUMBAGO ON JAN 21, 2019, THE PATIENT HAD A REVISION HIP JOINT TO ADDRESS ARTHROFIBROSIS AFTER HIP TEP RIGHT WITH SCARRING. THERE WAS NO MENTION OF THE REMOVAL OF ANY COMPONENTS. (18.D8.20T8 POTENTIALLY THOUGHT TO BE 19.08.2019 ) THE PATIENT HAD THE DIAGNOSIS OF INLAY SUBLUXATION WITH A JOINT PROSTHESIS ON THE RIGHT. THE INLAY WAS NOTED TO BE DEPUY THAT WAS IMPLANTED. PRIOR TO SURGERY, THE PATIENT WAS NOTED TO HAVE HAD A FALL. THE MEDICAL TRANSLATION PROVIDED WAS DIFFICULT TO UNDERSTAND. IT APPEARED THAT THE LINER WAS TILTED IN THE CUP AND THERE WAS WEAR PRESENT ON THE LINER. IT IS UNCLEAR IF THE SAME LINER WAS PLACED BACK IN THE PATIENT OR IF A NEW LINER OF THE SAME SIZE WAS POSITIONED. FOR THE PURPOSE OF THIS REVIEW, IT WILL BE ASSUMED A NEW LINER WAS PLACED. THE FEMORAL HEAD WAS REVISED AND A LARGER HEAD WAS PLACED.

  Patient problems: Adhesion(s); Discomfort; Fall; Hematoma; Joint Laxity; Pain; Scar Tissue

  MAUDE report 13051850 ↗
• MalfunctionNov 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT IN 2008 THE IMPLANT WAS INSTALLED, IN 2021 - ULTRASOUND REVEALED THE RUPTURE OF THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 12851312 ↗
• InjuryApr 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO MECHANICAL COMPLICATION OF INTERNAL JOINT IMPLANT. THE SURGEON NOTED A HEMATOMA, DISCOLORATION FROM METAL ABRASION, AND THE REMOVAL OF SCAR TISSUE. THE LINER WAS WORN AND DISASSOCIATED FROM THE CUP WITH MINOR CONTACT OF THE HEAD AGAINST THE METAL RING. THE HEAD AND LINER WERE EXCHANGED. THE CUP AND STEM WERE RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma

  MAUDE report 11649716 ↗
• InjuryMar 10, 2021Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT WAS REVISED AGAIN BECAUSE OF ISSUES WITH THE PE INLAY. DOR UNKNOWN; ALL ACETABULAR COMPONENTS WERE REVISED. THE MOST RECENT REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE OPERATIVE TIME WAS NOT PROLONGED. IN THIS PATIENT, REVISION SURGERY WAS REQUIRED DUE TO SUBLUXATION OF THE FEMORAL HEAD WITH DISLOCATION OF THE CUP INLAY THAT WAS PLACED DURING THE MOST RECENT REVISION, SQUEAKING SOUNDS, AND A SENSE OF INSTABILITY. THE REPEAT REVISION SURGERY WAS THE ADVERSE CONSEQUENCE OF THE COMPLICATION.

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

  MAUDE report 11452853 ↗
• MalfunctionDec 4, 2020Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING A PRIMARY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944469 ↗
• MalfunctionDec 3, 2020Difficult to Insert; Difficult to Insert

  THE APEX HOLE ELIMINATOR CAN BE SCREWED DOWN THROUGH THE CUP. SURGERY TIME EXTENDED 10 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 10942608 ↗
• MalfunctionOct 1, 2020Difficult to Insert; Difficult to Insert

  SURGEON IMPLANTED A PINNACLE 100 CUP AND THEN WANTED TO INSERT THE HOLE ELIMINATOR SCREW. THIS COULD JUST BE SCREWED THROUGH AND SHOWED NO RESISTANCE/HOLD/STOP. WHEN SURGEON NOTICED THAT THE SCREW WAS PROBABLY NOT RUNNING TIGHT, HE COULDN'T TURN IT BACK EITHER. THE LOCKING SCREW IS CLEARLY TOO DEEP. NO SURGERY DELAY REPORTED.

  Patient problems: No Code Available

  MAUDE report 10613229 ↗
• MalfunctionSep 29, 2020Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAPPENED DURING A PRIMARY SURGERY. AFFECTED SIDE: RIGHT.

  Patient problems: No Code Available

  MAUDE report 10600398 ↗
• MalfunctionJul 30, 2020Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE TIME OF SURGERY WASN¿T EXTEND AND THERE WERE NO ADDITIONAL CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347555 ↗
• InjuryJul 6, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  SURGEON IS REPORTING A REVISION OF AN UNKNOWN PINNACLE INLAY UNKNOWN SIDE BECAUSE OF FRACTURE OF INLAY A SURGICAL DELAY WAS NOT REPORTED. DOI: (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 10232868 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT WAS IMPLANTED WITH A METAL-ON-METAL PINNACLE DEVICE AND UNDERWENT A PAINFUL AND RISKY REVISION SURGERY. DOI: (B)(6) 2006. DOR: (B)(6) 2016, (LEFT HIP). PATIENT IS BILATERAL. PLEASE SEE (B)(4) FOR THE RIGHT HIP.

  Patient problems: Cardiac Arrest; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9519359 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT WAS IMPLANTED WITH A METAL-ON-METAL PINNACLE DEVICE. DOI: (B)(6) 2005; DOR: NONE REPORTED (RIGHT HIP). PATIENT IS BILATERAL. PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Cardiac Arrest; Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain

  MAUDE report 9519343 ↗
• InjuryDec 4, 2019Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY. PATIENT COMPLAINED LIMITED RANGE OF MOTION AND DISCOMFORT ON INTERNAL ROTATION. THERE IS ECCENTRIC POSITIONING OF THE FEMORAL HEAD WITHIN THE ACETABULUM CONSISTENT WITH POLYETHYLENE WEAR. REVISION NOTES STATED THERE WAS ABUNDANT AMOUNT OF METALLOSIS AND LARGE PSEUDOTUMOR. THE LINER WAS CLEARLY BROKEN AND DISASSOCIATED FROM THE CUP. CUP, LINER AND METAL HEAD WERE REMOVED. THERE WAS IMPINGEMENT ANTERIORLY AND RIGHT LEG LENGTHS WERE A COUPLE MILLIMETERS SHORT COMPARED TO CONTRALATERAL SIDE. DOI: (B)(6) 2016 AND DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; No Code Available; Pain; Physical Asymmetry; Unspecified Musculoskeletal problem

  MAUDE report 9412502 ↗
• MalfunctionAug 21, 2019Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  INTRAOPERATIVELY THE APEX HOLE ELIMINATOR SPINNED THROUGH THE ALREADY IMPLANTED PINNACLE CUP. THE PINNACLE CUP WAS REMOVED AND HOLE ELIMINATOR WAS RETRIEVED. (SAME) CUP WAS INSERTED AGAIN. SURGERY PROLONGATION OF ABOUT 10 MINUTES WAS REPORTED.

  Patient problems: Insufficient Information; Not Applicable

  MAUDE report 8917799 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN AND GENERAL LITIGATION NOTES METAL ON METAL IMPLICATIONS. DOI: (B)(6) 2006; DOR: (B)(6) 2016; (LEFT HIP). UPDATE AD 04 MAR 2019: RECEIPT OF PFS, MEDICAL RECORDS AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES DISCOMFORT, LIMITED MOBILITY AND WALKING DIFFICULTY. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED SERAM METAL IONS. MRI SHOWED SOME SYNOVITIS. REVISION NOTES REPORTED SOME SCAR TISSUES AND DISRUPTION OF THE ANTERIOR PORTION OF THE GLUTEUS MEDIUS. METAL ION LEVELS WERE ABOVE 7PPB. PPF ALLEGES METAL WEAR, METALLOSIS AND EMBOLISM AFTER FIRST REVISION.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Pulmonary Embolism; Scar Tissue; Tissue Damage

  MAUDE report 8469075 ↗
• InjuryJan 11, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF THE CUP. DOI: (B)(6) 2003 - DOR: (B)(6) 2009 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8241852 ↗
• InjuryDec 4, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  SPLIT IN SEVERAL PARTS AND IS LOOSE IN THE PINNACLE CUP.

  Patient problems: Pain

  MAUDE report 8130421 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, MULTIPLE DISLOCATIONS AND LACK OF MOBILITY. RECORDS INDICATE THAT THE PATIENT WAS REVISED ON THE LEFT SIDE BECAUSE OF INSTABILITY AND METALLOSIS. PPF ALLEGES METALLOSIS, METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2004 - DOR: (B)(6) 2013 (RIGHT HIP).

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

  MAUDE report 8004247 ↗