PINNACLE POROCOAT 1217-22-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 10603295009832), received between Dec 23, 2014 and Jun 23, 2026 — classified as 260 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (39 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 263 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25595123 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ASSOCIATED WITH PROSTALAC. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25086573 ↗
• InjuryMar 3, 2026Use of Device Problem

  PATIENT WAS REVISED DUE TO IMPLANTS WERE REMOVED DUE TO CUP MALPOSITION CAUSING METALOSIS. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Foreign Body Reaction

  MAUDE report 24498501 ↗
• InjuryFeb 26, 2026Use of Device Problem

  PATIENT WAS REVISED DUE TO CUP WAS MALPOSITIONED, CREATING CHRONIC DISLOCATION. 54 CUP REMOVED, LINER REMOVED, HEAD REMOVED. CUP REVISION. DOI: UNKNOWN. DOR: (B)(^) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 24458107 ↗
• InjuryDec 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT HIP WAS DISLOCATED. UPON VIEW OF THE PATIENT X-RAY, IT WAS FOUND THAT THE ACETABULAR COMPONENT WAS MALPOSITIONED. THE CUP WAS VERTICAL AND DR. WANTED TO REVISE THE ACETABULAR COMPONENT. WHEN ASKED IF HE HAD ANY INFORMATION ON THE PATIENTS INITIAL SURGERY, HE SAID HE DIDN¿T HAVE ANY OF THE INFORMATION. HE WAS UNSURE OF WHERE THE PATIENT HAD THEIR SURGERY, WHO DID IT, OR WHEN IT WAS DONE. THE CUP WAS REMOVED AND THE PATIENT WAS PREPARED AND IMPLANTED WITH A REVISION MULTIHOLE CUP. AN ELEVATED RIM LINER WAS IMPLANTED AND A TRIAL REDUCTION WAS PERFORMED. STABILITY WAS CONFIRMED, SO THE REAL TS CERAMIC HEAD WAS OPENED AND IMPLANTED. HIP WAS REDUCED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23863883 ↗
• InjuryDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT AS REPORTED THAT THE PATIENT WAS REVISED FOR A DISASSOCIATED CUP. THE STEM WAS REPORTED STABLE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687695 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIS HIP REPLACED IN (B)(6) 2025 BY SURGEON. HE CAME INTO THE ER FEELING SICK, A FEVER, AND HIP PAIN. AFTER EXAMINATION IT WAS DETERMINED THAT HIS LEFT HIP WAS INFECTED. SURGEON DECIDED TO DO A REVISION SURGERY WHERE ALL THE IMPLANTS WERE EXPLANTED, A THOROUGH DEBRIDEMENT WAS DONE, AND THEN NEW COMPONENTS WERE IMPLANTED. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23328069 ↗
• InjurySep 17, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF RIGHT HIP CUP IN 2023 BECAUSE OF EARLY LOOSENING OF CUP. THE LOOSENING OCCURRED BETWEEN THE METAL CUP AND THE BONE. THE PATIENT WAS SATISFIED WITH THE SURGICAL OUTCOME FROM 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23076299 ↗
• InjurySep 16, 2025Adverse 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 INSTABILITY. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 23062262 ↗
• InjurySep 9, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THERE WAS ANTERIOR DISLOCATION TWO WEEKS POST-OP. DETERMINED TO HAVE TOO MUCH CUP ANTIVERSION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23004225 ↗
• InjuryAug 8, 2025Adverse 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 INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22751627 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS BEING REVISED DUE TO PAIN. SURGEON REMOVED THE 54MM PINNACLE CUP, TWO 30MM PINNACLE SCREW, THE 54- 36MM +410 DEGREE LINER AND THE 36 +8.5 ARTICULEZE HEAD. THESE WERE REPLACED WITH AN EMPHASYS 58MM THREE HOLE CUP, THREE SCREWS, A DUAL MOBILITY LINER AND DUAL MOBILITY HEAD WERE USED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 22636861 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED HIP. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22087744 ↗
• InjuryMar 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A THA SURGERY WITH ACTIS PRODUCTS AT ANOTHER HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, DISLOCATION OCCURRED. A CT SCAN REVEALED THAT THE CUP HAD BEEN INSERTED IN A SLIGHTLY POSTERIORLY TWISTED POSITION. ON (B)(6) 2025, REPLACEMENT OF THE CUP WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21689791 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CUP REVISION FOR INSTABILITY. UNKNOWN SURGICAL DELAY. DOI : UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21401750 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH PINNACLE ULTAMET AND EXPERIENCE METALOSIS, PSEUDOTUMOR. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 21311892 ↗
• InjuryJan 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO SURGICAL DELAY. THE SURGERY WAS THE RESULT OF THE DISLOCATION. NO PATIENT HARM OTHER THAN THEIR HIP LINER DISLOCATING FROM THE PINNACLE SHELL.

  Patient problems: Insufficient Information

  MAUDE report 21282065 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTED AND INFLAMED RIGHT HIP REPLACEMENT. THE PATIENT HAD PAIN ON WEIGHT BEARING. ALL COMPONENTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21125504 ↗
• InjuryNov 12, 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 INFECTED THA. REMOVED PARTS AND IMPLANTED A PROSTALAC 200M STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20666727 ↗
• InjuryOct 4, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. REMOVED CUP AND WENT BACK. REVISION CUP AND ADDED MORE ANTEVERSION. NO ADDITIONAL INFORMATION. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20369805 ↗
• InjuryAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER DISASSOCIATED FROM THE CUP ON TWO SEPARATE OCCASIONS. THE ORIGINAL SURGERY ON (B)(6) 2022. THE LINER WAS EXCHANGED ON (B)(6) 2023 AND CUP REVISED ON (B)(6) 2024. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE : LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20086858 ↗
• InjuryAug 28, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE METAL ON METAL LITIGATION FORM RECEIVED. LITIGATION ALLEGES PAIN IN HIP, METALLOSIS, ELEVATED LEVELS OF COBALT AND CHROMIUM, SOFT TISSUE DAMAGE, A CORRECTIVE SURGERY TO REMOVE THE DEFECTIVE PRODUCT AND OTHER PAINFUL INJURIES. DOI: (B)(6) 2011. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN SIDE OF HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 20085994 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19971376 ↗
• InjuryJun 12, 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 PAIN. IT WAS UNKNOWN WHETHER THERE WAS ANY LOOSENING. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP

  Patient problems: Pain

  MAUDE report 19519583 ↗
• InjuryMay 20, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  REVISION OF CORAIL/PINNACLE CONSTRUCT IMPLANTED (B)(6) 2023 BY SURGEON IN HOSPITAL. REASON FOR REVISION WAS PAIN/SUSPECTED LOOSENING OF STEM/BONE INTERFACE. THE STEM, HEAD, AND LINER WERE TAKEN OUT IN THE REVISION SURGERY. THE CUP WAS LEFT IN PLACE.

  Patient problems: Pain

  MAUDE report 19353146 ↗