PINNACLE POROCOAT 1217-22-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 253 adverse event reports that list this exact device (DI 10603295009818), received between Jan 28, 2016 and Sep 23, 2026 — classified as 227 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (32 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 253 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient is unstable. The cup and liner were taken out and their position was changed during a revision procedure.DOI: (b)(6) 2010.DOR: (b)(6) 2026.Affected side: Left hip.

  Patient problems: Joint Laxity

  MAUDE report 50873099 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on March 23, 2009, patient had a surgery of total hip arthroplasty indicated for osteoarthritis of the left hip.(b)(6) 2024: Patient is experiencing left knee pain for 3 weeks. Pain is expected to be secondary to left knee osteoarthritis with exacerbation. No implants are currently present in the knee. Patient underwent a left knee injection and arthrocentesis.On (b)(6) 2025, patient was revised due to developing pain in the left hip. Patient has a history of metal-on-metal prosthesis on both sides. Patient had metal ions assessed which unfortunately were significantly elevated. Through the operation, it was identified there was some mildly hemorrhagic bursitis which was carefully debrided. There were some inflamed synovial fronds both anteriorly and posteriorly and these were debrided. There was significant bony overgrowth anteriorly and this was debrided.Patient reports experiencing a sensation of grinding in her hip when bending over to tie her shoe but does not experience any associated pain. Patient recalls an isolated incident of pain on the contralateral side but has not experienced any subsequent discomfort. Patient reports satisfactory progress with her lef

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Metal Related Pathology; Pain; Synovitis

  MAUDE report 50692180 ↗
• InjuryDec 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ORIGINAL CASE WAS DONE SEVEN YEARS AGO DUE TO INSTABILITY. PATIENT DISLOCATED PINNACLE CONSTRAINED LINER. DOCTOR STATED THAT THE CUP WAS NOT IN AN OPTIMAL POSITION AND WAS VERTICAL. THERE WAS VISIBLE IMPINGEMENT BETWEEN THE CUP AND TRUNNION. NOTICEABLE METALLOSIS ON THE TISSUES. DOCTOR CUT OUT THE PINNACLE CUP AND REPLACED IT WITH A READAPT CUP; REMOVED THE HEAD, CUP, LINER AND SCREWS. REPLACED WITH A +12 TO INSURE STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Laxity

  MAUDE report 23803855 ↗
• InjuryNov 4, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ALL IMPLANTS APPEARED TO BE LOOSE. NO PATIENT COMPLICATIONS. AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23467948 ↗
• InjuryOct 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WITH A PINNACLE CUP, LUXATES AND NEED TO HAVE A CUSTOM-MADE PINNACLE DUAL MOBILITY SOLUTION.

  Patient problems: Joint Laxity

  MAUDE report 23328109 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL HIP SURGERY DONE (B)(6) 2025 AT OSI SURGERY CENTER BY DR. UNFORTUNATELY THE PATIENTS HIP BECAME INFECTED. DR. OPTED TO DO AN IMMEDIATE EXCHANGE WHERE HE WAS GOING TO TAKE OUT ALL THE IMPLANTS, THOROUGHLY WASHOUT THE HIP, THEN IMPLANT NEW COMPONENTS. THE PATIENT WAS PREPPED WITH A 52MM EMPHASYS CUP, WHICH ALLOWED DR. TO UTILIZE A 40MM LINER FOR ADDED STABILITY. THE FEMORAL CANAL WAS THEN PREPPED FOR A 5HI STEM AND A TRIAL REDUCTION WAS PERFORMED WITH A 40MM +1.5 HEAD. DR. FELT THAT THE 40 +5 WAS BETTER AND IMPLANTED IT. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES DOI: (B)(6) 2025, DOE: UNKNOWN , AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23069115 ↗
• InjuryJul 15, 2025Migration; Migration

  IT WAS REPORTED THAT SURGEON DID FIRST SURGERY (B)(6) 2025 SAID ON FOLLOW UP APPOINTMENT NOTICED CUP HAD SHIFTED & WANTED TO RE-IMPLANT A MULTI HOLE WITH POSSIBLE DUAL MOBILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22506909 ↗
• InjuryJun 10, 2025Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HIP PAIN AND AUDIBLE SQUEAKING ON MOVEMENT POSTOPERATIVELY AFTER A TOTAL HIP REPLACEMENT. IMAGING SHOWED ECCENTRIC FEMORAL HEAD POSITION WITHIN THE SHELL: SUSPICIOUS FOR POLYETHYLENE LINER WEAR OR DISSOCIATION.THERE WAS NO TRAUMA. STEM APPEARS WELL FIXED. REVISION WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 22175402 ↗
• InjuryMay 22, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A PINNACLE IMPLANT ON (B)(6) 2010. EVENTUALLY, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO THE FOLLOWING SYMPTOMS: SOFT TISSUE REACTION: ADVERSE LOCAL TISSUE REACTION (ALTR), ADVERSE REACTION TO METAL DEBRIS (ARMD), METALLOSIS, ASEPTIC LYMPHOCYTIC VASCULITIS ASSOCIATED LESIONS (ALVAL). DOI: (B)(6) 2010. DOR: (B)(6) 2014. AFFECTED SIDE: UNK HIP.

  Patient problems: Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 22072001 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (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 INSTABILITY. AT REVISION THERE WAS METAL WEAR OF THE FEMORAL HEAD. AT REVISION THERE WAS SEVERE YELLOWING AND NECK IMPINGEMENT AT REVISION.

  Patient problems: Joint Laxity

  MAUDE report 21978522 ↗
• InjuryMay 1, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE PATIENT HAD A SPINE FUSION AND SUBSEQUENT HIP DISLOCATIONS. INSTABILITY AND MALPOSITION ARE THE REASONS FOR THE REVISION. THE LINER WAS BROKEN; ALL PIECES WERE RETRIEVED, AND THE CUP REVISION WAS PERFORMED. NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Nerve Damage

  MAUDE report 21943981 ↗
• MalfunctionApr 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THA, WHEN THE SURGEON INSERTED THE ACETABULAR CUP AND WAS INSERTING THE APEX HOLE ELIMINATOR, THE HOLE ELIMINATOR FELL THROUGH THE APEX HOLE IN THE CUP. THE SURGEON TRIED TO FISH THE HOLE ELIMINATOR OUT WITH GILLIES AND A SCREWDRIVER BUT WAS UNABLE TO. THE SURGEON REMOVED THE CUP AND PULLED OUT THE APEX HOLE ELIMINATOR. THE HOLE ELIMINATOR WAS TESTED IN A TRIAL CUP AND ENGAGED AS INTENDED. THE SURGEON WAS ABLE TO REINSERT THE ACETABULAR CUP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE (3) MINUTE DELAY AND NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21908972 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANTATION OF THE THA DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21872861 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HIP REVISION SURGERY WAS PLANNED FOR (B)(6) 2024 DUE TO THE PATIENT'S PAIN.

  Patient problems: Pain

  MAUDE report 21294952 ↗
• InjuryJan 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CLAIMS THAT AS A RESULT OF THE PRODUCT, PATIENT EXPERIENCED PAIN AND WAS DIAGNOSED WITH HEMATOLOGICAL DISEASES CAUSED BY THE RELEASE OF METAL IONS. CONSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY, ALTHOUGH FURTHER DETAILS OF THE SECOND SURGERY HAVE NOT BEEN PROVIDED. DOI: 2018, DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21051843 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. THE KA STEM WAS GROSSLY LOOSE AND CAME RIGHT OUT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20629158 ↗
• InjuryOct 15, 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 PAIN AND IMPLANT FRACTURED STEM. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY. PROCEDURE RELATED: DEFINITELY NOT. DATE OF EVENT: 3/OCT/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Pain

  MAUDE report 20451598 ↗
• InjurySep 20, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS CHRONICALLY DISLOCATING. THE CUP WAS REMOVED AND COMPONENTS REPLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20267059 ↗
• MalfunctionSep 17, 2024Off-Label Use; Device Contaminated During Manufacture or Shipping; Off-Label Use; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON SEPTEMBER 5, 2024, THE PATIENT UNDERWENT A SURGERY VIA THA. DURING THE SURGERY, A NURSE NOTICED A LITTLE BLACK SUBSTANCE ADHERED ON THE IMPLANT WHEN HE/SHE WAS OPENED THE IMPLANT. THE SURGEON COULD NOT CONFIRM THE ADHERED SUBSTANCE. WHEN THE ASSISTANT SURGEON TOUCHED THE SUBSTANCE WITH HIS/HER HAND, IT WAS REMOVED. THEREFORE, THE IMPLANT WAS WASHED AND USED IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236918 ↗
• InjurySep 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED, DUE TO LINER DISSOCIATION. SCREW WAS POTENTIALLY LEFT PROUD. DOI: (B)(6) 2018, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20211347 ↗
• InjurySep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE DISLOCATION. HIP CUP CHANGED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20147869 ↗
• InjuryJul 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PARTIAL REVISION SURGERY OF YEAR 2023: INSERT DISLOCATION/MOBILIZATION. HEAD AND INSERT REPLACED. DOI: (B)(6) 2016. DOE: (B)(6) 2023.

  Patient problems: Loss of Range of Motion

  MAUDE report 19791265 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUP REVISION SURGERY AFTER 10 YEARS FROM IMPLANT.

  Patient problems: Foreign Body Reaction

  MAUDE report 19782025 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS LEFT HIP PAIN. OPERATIVE NOTE REPORTED A SCAR TISSUE AND THERE WERE NO ABDUCTORS. DOI: (B)(6) 2009; DOR: (B)(6) 2012; LEFT HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Pain; Unspecified Tissue Injury

  MAUDE report 19654751 ↗
• InjuryJun 27, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE VERTICAL CUP EVENTUALLY LED TO SUPERIOR POLY WEAR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19625240 ↗