PINNACLE POROCOAT 1217-01-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10603295008552), received between Aug 26, 2013 and Aug 5, 2026 — classified as 74 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (18 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 95 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to surgeon suspicion of instability. There was no other information known.DOI: Unknown. DOR: on (b)(6) 2026. Affected side: Left Hip.

  Patient problems: Joint Laxity

  MAUDE report 50147242 ↗
• MalfunctionMar 5, 2026Difficult to Remove

  IT WAS REPORTED THAT PINNACLE 100 ACET CUP 52MM AND DELTA CER INSERT 36ID X 62OD WERE INVOLVED IN AN INTRAOPERATIVE EVENT. DURING THE PROCEDURE, THE SURGEON WAS DISSATISFIED WITH THE POSITIONING OF THE LINER AND ATTEMPTED TO REMOVE IT, WHICH RESULTED IN THE CUP BEING UNINTENTIONALLY EXTRACTED FROM THE PATIENT. THE SURGEON PROCEEDED TO USE A NEW LINER AND CUP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FRAGMENTS WERE GENERATED. BOTH THE CUP AND LINER WERE EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24518588 ↗
• InjuryDec 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED LEGAL RECORDS WERE RECEIVED. THERE IS GAS AND SOFT TISSUE SWELLING SURROUNDING THE LEFT PROXIMAL FEMUR COMPATIBLE WITH POSTOPERATIVE CHANGES. LOOSENING OF FEMORAL COMPONENT OF PROSTHETIC LEFT HIP, SYNOVIAL FLUID FROM HIP JOINT, LEFT ARTHRITISM, PROGRESSIVE HIP PAIN AND DISABILITY. 10 ML OF BLACK STAINED FLUID, ACUTE METAL WEAR PROCESS, POLYETHYLENE LINER WAS WORN THROUGH SUPERIORLY AND BROKEN IN THE SUPERIOR RIM. THE CERAMIC BALL WAS NOTED TO HAVE BLACK STAINING ON THE SUPERIOR SURFACE, WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT HIP JOINT, INITIAL ENCOUNTER (CMS/HCC). HAD SEVERE BACK PAIN/MUSCLE SPASMS. COBALT LEVEL OF 77.1 AND A CHROMIUM LEVEL OF 40.1. DURING THE PROCEDURE, APPROXIMATELY 9 ML OF YELLOWISH FLUID WERE REMOVED. MODERATE AMOUNT OF SCAR TISSUE WHICH WAS STAINED BLACK CONSISTENT WITH A METAL STAINING. SCAR TISSUE WAS EXCISED AROUND THE TRUNNION AND THE ACETABULUM CIRCUMFERENTIALLY. LEFT HIP SORENESS, WEAKNESS, AND DECREASED RECALL OF POSTERIOR. FIBROSIS, FOCAL INFARCTION AND HISTIOCYTIC REACTION SPECIMEN SUBMITTED AS SYNOVIAL SCAR TISSUE CONSISTS OF AN IRREGULAR RUBBERY SEGMENT OF TAN GRAY-RED SOFT TISSUE RECEIVED IN FORMALIN MEASURING

  Patient problems: Adhesion(s); Discomfort; Fatigue; Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 23726248 ↗
• InjuryAug 8, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT DISLOCATED MULTIPLE TIMES. SURGEON WANTED TO USE A CONSTRAINED LINER. THE SURGEON REMOVED THE HEAD, LINER, HOLE ELIMINATOR, AND CUP. THE SURGEON REAMED UP TO 53MM REAMER. THE SURGEON IMPLANTED NEW 54 CUP AND PLACED NEW CONSTRAINED POLY IN NEW CUP TO ENSURE THIS NON-COMPLIANT PATIENT WOULD HAVE THE BEST CHANCES OF NOT DISLOCATING IN THE FUTURE. DOI: (B)(6) 2019, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22751343 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20867115 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 MEDICAL RECORDS NOTE THE PATIENT IS EXPERIENCING SOME NUMBNESS AND TINGLING DOWN THE RIGHT LEG, ALONG WITH RIGHT GROIN PAIN AND WEAKNESS ON (B)(6) 2021 MEDICAL RECORDS NOTE PATIENT HAS BEEN HAVING INCREASED WEAKNESS OF THE ILIOPSOAS MUSCLE RIGHT HIP, THE PATIENT IS SCHEDULED FOR AN INJECTION IN THE ILIOPSOASA MUSCLE. ON (B)(6) 2021 THE PATIENT HAD ILIOPSOAS TENDON INJECTION UNDER FLUOROSCOPIC GUIDANCE TO ADDRESS RIGHT HIP PAIN, ILIOPSOAS BURSITIS, TENDONITIS. NOTED THAT THESE EVENTS HAPPENED AFTER THE 02/18/2019, POST RIGHT HIP REVISION CAPTURED IN (B)(4).

  Patient problems: Fatigue; Inflammation; Muscle/Tendon Damage; Numbness; Pain

  MAUDE report 19462066 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE REACTION TO METAL DEBRIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2010 DATE OF EVENT: (B)(6)2024. (RIGHT HIP) TREATMENT: NONE.

  Patient problems: Foreign Body Reaction

  MAUDE report 19460848 ↗
• InjuryFeb 20, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2011, THE PATIENT HAD A RIGHT HIP ARTHROPLASTY TO ADDRESS POST TRAUMATIC ARTHRITIS, RIGHT HIP. THE PATIENT HAD A HISTORY OF A TRAUMATIC HIP INJURY PREVIOUSLY. THE PATIENT WAS IMPLANTED WITH DEPUY COMPONENTS DURING THIS PROCEDURE. THESE IMPLANTS INCLUDED A METAL INSERT AND CERAMIC FEMORAL HEAD ALONG WITH PINNACLE SHELL AND SUMMIT STEM. ON (B)(6) 2019, THE PATIENT HAD A REVISION RIGHT TOTAL HIP REPLACEMENT TO ADDRESS CHRONIC GROIN PAIN WITH METALLOSIS AND IMPINGEMENT. DURING THE PROCEDURE, THE SURGEON OBSERVED METALLOSIS, THE CUP WAS AT APPROXIMATELY 10 DEGREES OF ANTEVERSION, THEREFORE THE SHELL WAS REMOVED. THE STEM WAS NOTED TO BE WELL FIXED WITH APPROPRIATE AMOUNT OF ANTEVERSION AND RETAINED. A COMPETITOR SHELL DUAL MOBILITY CERAMIC / POLYETHYLENE BALL CONSTRUCT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT HAD A COMPLEX REVISION RIGHT TOTAL HIP ARTHROPLASTY, RADICAL RESECTION OF SCAR, TO ADDRESS RIGHT HIP ASEPTIC LOOSENING. PRIOR TO SURGERY, THE PATIENT REPORTED HAVING PAIN, DEBILITATING HIP ARTHROSIS, IMPAIRED DAILY FUNCTION. COMPETITOR SHELL, DUAL MOBILITY LINER, AND DEPUY FEMORAL HEAD WERE REVISED. DEPUY PINNACLE CEMENTLESS CUP WAS IMPLANTED ALONG WITH CROSS-LINKED POL

  Patient problems: Adhesion(s); Foreign Body Reaction; Joint Laxity; Pain; Scar Tissue

  MAUDE report 18737549 ↗
• InjuryJun 2, 2023Use of Device Problem; Use of Device Problem

  TOTAL HIP REVISION. LINER WAS COMPLETELY WORN OUT FROM ONE SIDE. PRIMARY OPERATION WAS (B)(6) 2018. SURGEON COMMENTED THAT THE CUP ITSELF WAS UPRIGHT TOO MUCH SO ON WRONG POSITION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 60. ACTION TAKEN WHEN EVENT OCCURRED? WORN IMPLANT WERE TAKEN OUT. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. OTHER INFORMATION: N/A. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE.

  Patient problems: Insufficient Information

  MAUDE report 17046760 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HCP IS REPORTING TO BFARM/NCA: "REVISION SURGERY OF THE RIGHT HIP JOINT WITH CUP REPLACEMENT ON (B)(6) 2023 BECAUSE DISLOCATION OF THE PE INLAY FROM THE METAL CUP WITH CONSECUTIVE CONTACT OF THE CERAMIC HEAD WITH THE METAL CUP." DOI: SEP 2011, DOR: ON (B)(6) 2023, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16680922 ↗
• InjuryFeb 17, 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) 2019. REVISION OF INLAY AND HIP HEAD ON (B)(6) 2023 AS INLAY DISASSOCIATED FROM CUP.

  Patient problems: Discomfort; Joint Laxity; Pain

  MAUDE report 16395751 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUERY INFECTION AND SURGEON DECIDED TO TAKE THE IMPLANTS OUT THAT WHERE IN SITU IN 2018. DOI: (B)(6) 2018. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15959890 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT REFERENCE TO (B)(4). REVISION SURGERY. PHYSICIAN REPORTED METALLOSIS. AFTER SOME TIME JUST BEFORE THE REVISION THE HEAD AND THE CUP WERE ARTICULATING TOGETHER ON A SMALL SPACE WHERE THE LINER WAS MOST BADLY DAMAGED. PHYSICIAN USED ANOTHER ONE COMPANY PRODUCT TO PROCEDURE COMPLETED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Foreign Body Reaction

  MAUDE report 15527826 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES FRICTION AND WEAR BETWEEN COBALT-CHROMIUM HEAD AND LINER CAUSING ELEVATED METAL IONS AND PARTICLES IN PLAINTIFF BLOOD, TISSUE AND BONE RESULTING TO INFLAMMATION, MENTAL AND EMOTIONAL INJURIES, PAIN AND DISCOMFORT WHEN AMBULATING. DOI: (B)(6) 2010, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Depression; Discomfort; Fall; Fatigue; Foreign Body Reaction; Inflammation; Loss of Range of Motion; Numbness; Pain; Pulmonary Embolism; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 14653335 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. PATIENT COMPLAINED OF REDDENED AREA AROUND INCISION SITE. THE PATIENT WAS THEN REVISED DUE TO INFECTED LEFT THA. OPERATIVE NOTES REPORTED THAT THERE APPEARED TO BE PURULENT MATERIAL IN ALL AREAS EVEN CONTACTING THE METAL ON THE IMPLANTS. IT WAS ALSO INDICATED THAT THE PATIENT RECEIVED 4 U PRBC. DOI: (B)(6) 2003; DOR: (B)(6) 2006 LEFT HIP.

  Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Purulent Discharge; Unspecified Infection

  MAUDE report 13735174 ↗
• MalfunctionNov 19, 2021Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY THE APEX HOLE ELIMINATOR DID NOT STOP IN THE CUP´S HOLE AS IT SHOULD. IT WAS POSSIBLE TO SCREW THE HOLE ELIMINATOR TOO DEEP. IT NOW SHOWS UP PROMINENT AT THE CUP´S DOME IN X-RAY. RIGHT SIDE, INITIAL SURGERY. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847241 ↗
• MalfunctionOct 11, 2021Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY THE HOLE ELIMINATOR DID NOT STOP IN THE CUP´S HOLE AS IT SHOULD. IT WAS POSSIBLE TO SCREW THE HOLE ELIMINATOR TOO DEEP. IT NOW SHOWS UP PROMINENT AT THE CUP´S DOME IN X-RAY. UNKNOWN SIDE, INITIAL SURGERY. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605144 ↗
• InjuryMar 23, 2021Use of Device Problem; Use of Device Problem

  THE CUP HAD TO BE REVISED DUE TO PAIN SECONDARY TO INSUFFICIENT ANTEVERSION OF THE CUP WHICH CAUSED A CONFLICT WITH THE PSOAS TENDON. DOR: (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 11552402 ↗
• MalfunctionMar 3, 2021Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY DURING PRIMARY HIP-TEP LEFT SIDE THE APEX HOLE ELIMINATOR DID HOLD IN THE CUP. SURGEON WAS ABLE TO REMOVE THE APEX HE. CUP REMAINED IMPLANTED WITHOUT APEX HE. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404900 ↗
• MalfunctionFeb 25, 2021Difficult to Insert; Difficult to Insert

  HCP SENT AN E-MAIL TO SALES REP: ON (B)(6) 2021 SURGEON HAD ISSUES WITH THE APEX HOLE ELIMINATOR, LOT D20091400. A THREAD-ERROR OCCURRED. THE HOLE ELIMINATOR WAS SCRAPPED BY HOSPITAL AND ANOTHER APEX HE WAS USED WITHOUT ISSUES. NO SURGICAL DELAY REPORTED, NO ADVERSE PATIENT AND/OR USER CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377726 ↗
• InjuryFeb 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PFS MENTIONS: TISSUE DAMAGE, DEEP VENOUS THROMBOSIS, PULMONARY EMBOLISM, ANTIPHOSPHOLIPID SYNDROME, NEED FOR CHRONIC ANTICOAGULATION THERAPY, AT RISK FOR A MULTITUDE OF ISSUES INCLUDING FALLS, TWO SECONDARY REVISION SURGERIES TO REPLACE THE FAULTY DEVICES, EXTENSIVE REHABILITATION, ECONOMIC LOSS, PAIN AND SUFFERING THAT BEGAN IN 2011. THE PFS MENTIONED CONTINUED PAIN AND UNABLE TO LIFT RIGHT LEG DUE TO PAIN AND LIMITATIONS IN MOVEMENT OF RIGHT HIP DUE TO METALLOSIS AND TISSUE DAMAGE. ON 03/17/2010, PATIENT HAD A LEFT HIP ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATIENT HAD A DISCHARGE DIAGNOSIS OF ACUTE BLOOD LOSS ANEMIA, STATUS POST LEFT TOTAL HIP ARTHROPLASTY. DEPUY PRODUCTS WERE PLACED DURING THIS PROCEDURE. ON 09/01/2010, THE PATIENT HAD A RIGHT HIP ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. 02/12/2019 MEDICAL RECORDS NOTE PATIENT IS RETURNING FOR FOLLOW-UP FOR RIGHT HIP. PATIENT HAS HAD SEVERE GROIN PAIN. MEDICAL CONDITION INCLUDES: PHLEBITIS, PULMONARY EMBOLISM. *NO MENTION OF WHEN THE PULMONARY EMBOLISM OCCURRED. ON 02/18/2019, THE PATIENT HAD

  Patient problems: Ambulation or Postural Difficulties; Depression; Discomfort; Fall; Fatigue; Fibrosis; Foreign Body Reaction; Inflammation; Loss of Range of Motion; Numbness; Pain; Physical Asymmetry; Pulmonary Embolism; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 11333746 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 11331573 ↗
• MalfunctionJan 6, 2021Difficult to Insert; Difficult to Insert

  APEX HOLE ELIMINATOR IS ROTATED THROUGH THE PINNACLE CUP.

  Patient problems: Insufficient Information

  MAUDE report 11123461 ↗
• MalfunctionNov 30, 2020Difficult to Insert; Difficult to Insert

  THIS APEX HOLE ELIMINATOR WENT STRAIGHT THROUGH PINNACLE CUP WHEN INSERTING IT. IT DID NOT STOP. DR P. TOOK BOTH OUT FROM THE PATIENT AND INSERTED NEW CUP AND NEW APEX SCREW.

  Patient problems: Insufficient Information

  MAUDE report 10920355 ↗
• MalfunctionNov 18, 2020Difficult to Insert; Difficult to Insert

  THIS APEX HOLE ELIMINATOR DID NOT STOP WHEN INSERTING IT TO THE PINNACLE CUP, IT WENT STRAIGHT THROUGH. THE SURGEON LEFT IT BEHIND THE CUP, BECAUSE CUP HAD VERY GOOD GRIP.

  Patient problems: No Code Available

  MAUDE report 10862772 ↗