PINNACLE POROCOAT 1217-01-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10603295008545), received between May 25, 2017 and Jul 27, 2026 — classified as 70 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 84 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Device Dislodged or Dislocated

  It was reported that patient underwent total hip arthroplasty (THA) on (b)(6) 2024. The then presented to the emergency department on (b)(6) 2026, complaining of severe pain in the left hip which had worsened significantly since the previous evening. Weight-bearing on the left leg was barely possible; the patient denied any preceding trauma. The patient had repeatedly noticed a "grinding" or "popping" sensation in the left hip while walking.An earlier consultation on (b)(6) 2026, due to increasing hip discomfort, had revealed no radiological or CT evidence of prosthesis loosening, periprosthetic fracture, or inlay dislocation. At that time, the femoral head appeared properly centered within the acetabular component. Current diagnostic imaging revealed an eccentric position of the prosthetic head within the acetabular component. CT findings raised suspicion of inlay dislocation or a material defect in the hip prosthesis. Additionally, an extensive periprosthetic fluid collection containing air pockets was noted. However, clinical and laboratory findings showed no evidence of an acute infection.Based on these findings, an indication for emergency surgical revision was established. Cu

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 50045238 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH LEFT PINNACLE MOM HIP SYSTEM DUE TO DEGENERATIVE ARTHRITIS IN THE HIPS. PATIENT EXPERIENCED PAIN, GOT WORSE WHEN SITTING BUT IS NOT AS SEVERE AS ON THE RIGHT HIP. ELEVATED CHROMIUM AND COBALT LEVEL IN THE BLOOD. ERYTHROCYTE SEDIMENTATION RATE IS ALSO HIGH. EXTENSIVE PARTIAL TEARING LEFT HAMSTRING TENDON. DOI: (B)(6) 2008, DOR: UNK, LEFT HIP.

  Patient problems: Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 24817593 ↗
• InjuryAug 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF TOTAL HIP REPLACEMENT DUE TO SUSPECTED SUBLUXATION/INLAY DISLOCATION ON X-RAY. THE PATIENT COMPLAINED OF PAIN AND A FEELING OF INSECURITY AND HAD TO UNDERGO REVISION SURGERY WITH SUBSEQUENT REHABILITATION. INTRAOPERATIVELY, THERE WAS DISLOCATION OF THE INLAY AND FRACTURE OF THE INLAY. SURGEON PERFORMED INLAY REPLACEMENT, HEAD REPLACEMENT, MERETE NECK LENGTHENING. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22825854 ↗
• InjuryAug 8, 2025Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT UNDERWENT RIGHT THR EIGHTEEN MONTHS PRIOR. PROCEDURE WAS COMPLETED WITH NO PROBLEMS. THE PATIENT HAD TO BE REVISED DUE TO NINE MONTH HISTORY OF CLUNKING/SUBLUXATION AND SIX DAY HISTORY OF SQUEAKING. X-RAY SHOWED LINER DISSOCIATION. INTRAOPERATIVELY, THE LINER SPUN INFERIORLY WITH HEAD ARTICULATING WITH SHELL.

  Patient problems: Joint Laxity

  MAUDE report 22749284 ↗
• InjuryJul 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION FOR HIP REPLACEMENT AS LINER DISASSOCIATED WITH CUP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 22556255 ↗
• MalfunctionJun 3, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AFTER IMPLANTATION OF A HIP-TEP. REGARDING THE CUP AND APEX HOLE ELIMINATOR, THE PATIENT WAS GIVEN UNSUITABLE PARTS (THREAD DIAMETER TOO LARGE), JAMMING, ETC. THE PATIENT HAS HAD PAIN IN THIS LEG FOR ALMOST SIX YEARS, ON THE SIDE OF THE HIP, EVEN WHEN TURNING AT NIGHT, THERE'S NO VISIBLE LOOSENING. THE PATIENT'S WALKING DISTANCE HAS ALSO SHORTENED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 22135310 ↗
• InjuryNov 15, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE SURGEON REVISED A 18X13 30+4 S-ROM STEM AND A 50MM PINNACLE CUP. THE PINNACLE CUP WAS DETERMINED TO BE IMPLANTED TOO FLAT AND ANTEVERTED DURING A PREVIOUS OPERATION, WHICH HAD LED TO THE 32MM +6 CERAMIC BREAKING. THE S-ROM STEM WAS EXPLANTED AND A 18X13 36+12 STEM WAS IMPLANTED. THE CUP WAS EXPLANTED AND A 58MM REVISION CUP WITH A 36MM CERAMIC HEAD WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. THE NEW STEM PROVIDED GOOD STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20693929 ↗
• InjuryMay 17, 2024Device Dislodged or Dislocated; Osseointegration Problem; Noise, Audible; Device Dislodged or Dislocated; Osseointegration Problem; Noise, Audible

  THE PATIENT UNDERWENT LEFT HIP TEP REVISION WITH THE CHANGE OF INLAY AND PLUG-ON HEAD DUE TO INJURIES BY POOR JOINT MECHANICS, SQUEAKING OF THE IMPLANT, SUSPICION OF LOOSENING OF THE PROSTHESIS, PAIN, AND THEREFORE NECESSARY REVISION SURGERY ON BODY AND HEALTH. IMPLANT FAILURE. RADIOLOGICAL AND CLINICAL WITH MAINLY INLAY DISLOCATION OR FRACTURE. LOOSENING OF THE CUP, PROTRUDING OF THE APEX HOLE.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 19344613 ↗
• InjuryApr 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  SALES REP REPORTED: HE HAS REMOVED A PINNACLE INLAY, WHICH WAS COMPLETELY RUN AFTER CRANIAL. THERE WAS NO DELAY. ADDITIONAL EVENT INFORMATION: NO HARM; FEMALE PATIENT NOTICED A GRINDING NOISE IN HER HIP JOINT, NO PAIN. AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063383 ↗
• InjuryFeb 28, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED: WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? (B)(6) 2022. CAN YOU PLEASE PROVIDE THE DATE THE PATIENT WAS REVISED? (B)(6) 2024. PLEASE CONFIRM IF THE LINER DISASSOCIATED FROM THE CUP OR IF THE LINER DISLOCATED FROM THE HEAD? THE LINER DISASSOCIATED FROM THE CUP.

  Patient problems: Insufficient Information

  MAUDE report 18796796 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A, WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO B. IT WAS STATED THAT THE CORAIL PINNACLE METALOSE IN THE EVENT DESCRIPTION. YES, ULTAMET. C. PLEASE CLARIFY IF THERE WAS IMPLANT LOOSENING ELEVATED METAL IONS OR FOREIGN BODY REACTION, ETC. PLEASE KINDLY PROVIDE DETAILS. YES.

  Patient problems: Foreign Body Reaction

  MAUDE report 18181823 ↗
• InjuryJul 26, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO INSTRUMENT ISSUE DURING SURGERY AND THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17396791 ↗
• InjuryJun 28, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUP AND LINER WERE REMOVED AS THE SURGEON NOT LIKE THE ORIGINAL CUP PLACEMENT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17217230 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2022, THE PATIENT REPORTS HAVING BACK PAIN, RIGHT HIP PAIN, AND RIGHT LEG PAIN. ON (B)(6) 2023, THE PATIENT REPORTS HAVING PAIN IN LOWER BACK, WITH RADIATION TO THE RIGHT GROIN. THERE IS ASSOCIATED CHRONIC RIGHT LEG WEAKNESS CONTINUE TO WORSEN AND BILATERAL FEET NUMBNESS AND TINGLING. PATIENT HAS COMPLETED EXTENSIVE PHYSICAL THERAPY. DOI: (B)(6) 2009 (CUP AND STEM); DOI: (B)(6) 2022 (HEAD AND LINER); DOE: (B)(6) 2022; RIGHT HIP

  Patient problems: Fatigue; Inflammation; Numbness; Pain

  MAUDE report 16888036 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED IN THE MEDICAL RECORDS ACTIVE PROBLEM REPORTED TROCHANTERIC BURSITIS, HEMATOMA, DEPRESSION AND LIMITED ADL. DOI: (B)(6) 2009; DOR: (B)(6) 2021; RIGHT HIP FIRST REVISION.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Depression; Discomfort; Extraskeletal ossification; Fibrosis; Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Necrosis; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16843300 ↗
• InjuryMar 9, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  MEDICAL RECORDS RECEIVED: THE PATIENT WAS REVISED DUE TO : PROCEDURE: PAIN-ADJUSTED STRESS BUILD-UP. ON (B)(6) 2023, 2 WEEKS AGO SUDDEN SHOOTING PAIN IN THE RIGHT HIP, AND SQUEAKING NOISES WHEN MOVING YET NO TRAUMA. RIGHT HIP: IRRITABLE SCAR. NOTICEABLY LOOSE COLLATERAL LIGAMENT CONDITION CORRESPONDING TO AN INLAY OF THE TKA ON THE RIGHT THAT IS TOO LOW. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP. HIP WAS REVISED TO ADDRESS IMPLANT DISASSOCIATION OF THE ACETABULAR LINER FROM THE ACETABULAR CUP/FAILURE OF ITS LOCKING MECHANISM. IT WAS ALSO REPORTED THAT THERE WAS EDEMA AND PAIN, ATTRIBUTABLE TO THE DISASSOCIATION. DURING THE REVISION, FOREIGN BODY REACTIVITY IN THE FORM OF DISCOLORED FLUID WAS OBSERVED, MOST LIKELY CAUSED BY POLYETHYLENE WEAR DEBRIS. THE NOISE REPORTED CAN BE ATTRIBUTED TO THE FEMORAL HEAD RUBBING DIRECTLY ON THE METAL CUP; THERE WAS NO REPORTED WEAR DAMAGE TO EITHER THE HEAD OR CUP THOUGH. IT IS REASONABLE TO CONCLUDE THAT THE CUP AND LINER FAILURES CAUSED/CONTRIBUTED TO THE REPORTABLE FEATURES OF THIS EVENT, AS THE STRUCTURAL INTEGRITY OF THESE PRODUCTS AND THEIR LOCKING MECHANISM FEATURE, AND ITS RESISTANCE TO FAILURE, IS INHERENT TO THEIR PRODU

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

  MAUDE report 16512355 ↗
• InjuryFeb 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO CUP/LINER DISASSOCIATION. THIS PC IS ASSOCIATED WITH (B)(4), IN WHICH THE BROKEN NECK IS ADDRESSED.

  Patient problems: Insufficient Information

  MAUDE report 16378569 ↗
• InjuryJan 31, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO CUP SPUN INTO A SUB OPTIMAL POSITION AND PATIENT HAD MULTIPLE DISLOCATIONS AND CLOSED REDUCTIONS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16271835 ↗
• InjuryJan 13, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE ALTRX LINER WHICH REQUIRED REVISION SURGERY DUE TO DAMAGE. THIS WAS IMPLANTED ON (B)(6) 2021 AND A PORTION OF IT APPEARS TO HAVE DETACHED CIRCUMFERENTIALLY AND SUPERIOR TO THE ORIENTATION IN WHICH IT WAS IMPLANTED. THIS LEFT THE CERAMIC HEAD RUBBING UPON THE SHELL.

  Patient problems: Insufficient Information

  MAUDE report 16157511 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15716132 ↗
• InjurySep 8, 2022Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  SURGEON REPORTED TO BFARM: "ON (B)(6) THE PATIENT HAD SUDDEN GROIN PAIN ON THE RIGHT SIDE, SINCE (B)(6) THERE IS A SQUEAKING NOISE IN THE AREA OF THE RIGHT HIP JOINT. THE PATIENT PRESENTED HERSELF YESTERDAY IN THE DOCTOR'S OFFICE; THE INDICATION FOR A HIP TEP REPLACEMENT BECAUSE A DECENTERED HEAD IN THE CUP WAS GIVEN. (B)(6) 2017 IMPLANTATION OF A CEMENTLESS TOTAL ENDOPROSTHESIS RIGHT HIP (CORAIL STEM SIZE 10, HEAD SIZE 28/+5, PINNACLE CUP SIZE 50/28 MM). (B)(6) 2022 EXPLANTATION OF THE BROKEN INLAY. THE INLAY WAS ALSO LUXATED." DOI: (B)(6) 2017, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Pain; Physical Asymmetry; Scar Tissue

  MAUDE report 15378769 ↗
• InjuryAug 24, 2022Fracture; Use of Device Problem; Device Dislodged or Dislocated; Fracture; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE TOTAL HIP ARTHROPLASTY WITH THE PINNACLE PROCOAT, THE STEM, THE HEAD AND THE ALTRX FOR THE LEFT HIP JOINT AT (B)(6) HOSPITAL IN CHINA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT VISITED (B)(6) HOSPITAL FOR DISCOMFORT. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED. THE SURGEON MEASURED THE CUP WITH THE CT BEFORE THE SURGERY, AND THE CUP WAS 50 DEGREES AND HAD NOT MOVED THAT FAR. ACCORDING TO THE SURGEON, THE SEQUENCE OF THE EVENT IS AS FOLLOWS. FIRST, THE LIP OF THE OFFSET LINER WAS BROKEN, AND DISLOCATION OCCURRED. NEXT, THE LINER DISLOCATED, AND THE CERAMIC HEAD SCRATCHED AND DESTROYED THE CUP. THE WOUND WAS BLACK DUE TO METALLOSIS. THE SURGEON REMOVED THE HEAD, AND THE LINER WAS TAKEN OFF EASILY. THE SURGEON REMOVED THE CUP WITH AN EXPLANT TOOL. AFTER REMOVAL, THE SURGEON INSERTED ZB¿S DUAL MOBILITY AND A HEAD. THE HEAD AND THE CUP WILL BE REPLACED WITH OTHER COMPANY¿S CUP. ACCORDING TO THE SURGEON, AFTER DESTRUCTION OF POLYETHYLENE, THE CUP WAS BROKEN BY CERAMIC HEAD. NEXT, DISLOCATION OCCURRED, AND DESTRUCTION OF BONE MATRIX FLOOR WAS SUSPECTED. SINCE THE P

  Patient problems: Discomfort; Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 15282655 ↗
• InjuryAug 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  70-YEAR-OLD FEMALE PATIENT RECEIVED A LEFT HIP REVISION TO TREAT IMPINGEMENT SECONDARY TO DISLOCATION AND LINER DISASSOCIATION. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED METALLOSIS CAUSED BY METAL DEBRIS. THE LINER WAS DISASSOCIATED DUE TO LOCKING MECHANISM FAILURE, CAUSING THE SUMMIT FEMORAL STEM TO IMPINGE ON THE FAILED LOCKING RING GENERATING WEAR ON THE TRUNNION AND METAL DEBRIS. THE CUP AND STEM WERE WELL-FIXED AND RETAINED. THE PATIENT A BIMENTUM DUAL MOBILITY ARTICULATING SURFACE TO REPLACE THE REVISED HEAD AND LINER. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. HEAD, LINER AND STEM WERE REVISED. DOI: (B)(6) 2008(CUP, STEM). DOI: (B)(6) 2017(HEAD, LINER). DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Foreign Body Reaction; Unspecified Musculoskeletal problem

  MAUDE report 15232294 ↗
• InjuryAug 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  68-YEAR-OLD FEMALE PATIENT RECEIVED A RIGHT HIP REVISION TO TREAT DISLOCATION AND LINER DISASSOCIATION SECONDARY TO A PELVIC FRACTURE CAUSED BY A FALL. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED METALLOSIS CAUSED BY METAL DEBRIS. THE LINER WAS DISASSOCIATED DUE TO LOCKING MECHANISM FAILURE AND FRACTURED, CAUSING THE FEMORAL HEAD TO ARTICULATE ON THE CUP CAUSING METAL DEBRIS. ALL FRAGMENTS OF THE LINER WERE REMOVED, AND THE WORN FEMORAL HEAD WAS REVISED. THE CUP AND STEM WERE WELL-FIXED AND RETAINED. THE PATIENT RECEIVED ANOTHER ARTICULEZE FEMORAL HEAD AND PINNACLE CONSTRAINED LINER WITH LOCKING RING. DURING HIP REDUCTION, THE SURGEON IDENTIFIED SOME IMPINGEMENT THAT HE DEEMED APPROPRIATE FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. OF NOTE: TREATMENT FOR THE PELVIC FRACTURE WAS NOT INCLUDED IN THE OPERATIVE NOTES OR MEDICAL RECORDS. DOI: (B)(6) 2008(CUP). DOI: (B)(6) 2018(HEAD ,LINER). DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Fall; Foreign Body Reaction; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 15223768 ↗
• InjuryJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RECEIVED HIP-TEP UNKNOWN SIDE ABOUT TWO WEEKS AGO. ABOUT ONE WEEK AGO THE PATIENT PRESENTED WITH A DISLOCATED PE INLAY. HIP-HEAD HAD CONTACT TO THE INNER PART OF THE PINNACLE CUP. REVISION OF CUP, INLAY, AND HIP HEAD.

  Patient problems: Insufficient Information

  MAUDE report 15102784 ↗