PINNACLE POROCOAT 1217-22-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10603295009801), received between May 22, 2014 and Sep 18, 2026 — classified as 98 injuries, 6 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 104 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  It was reported the HCP reported to NCA/BfArM: Premature high-grade polyethylene wear with inlay subluxation and direct contact between the ceramic head and metal cup of the right hip joint occurred after implantation of a cement-free fixed total hip joint endoprosthesis in (b)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 50816436 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 25013781 ↗
• InjuryFeb 24, 2026Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED STATING: PATIENT CALLED THIS WRITER BACK ON (B)(6) 2026. SHE STATES THAT SHE HAS NO HISTORY OF FALLS BUT HER HIP FELT UNSTABLE AND LIKE IT WAS GOING TO "POP." DURING THE REVISION THE LINER WAS JAGGED AND BROKEN OFF. THE FEMORAL HEAD WAS BLACK AND "SCRAPED UP." THE SURGEON STATED THE HEAD RUBBING ON THE CUP WAS THE CAUSE OF THE SQUEAKING. DOI: 2018. DOR: 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24431255 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HER HIP REPLACED RECENTLY AND CAME INTO THE ER WITH AN INFECTION. THE SURGEON EXPLANTED ALL OF HER COMPONENTS AND DID A THOROUGH I&D AND REIMPLANTED A NEW STEM, CUP, DUAL MOBILITY HEAD AND LINER. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22981384 ↗
• InjuryAug 13, 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: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22797833 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SURGEON HAD A PATIENT PRESENTED WITH A DISASSOCIATED PINNACLE ALTRX LINER REQUIRING REVISION. THERE WAS LOOSENING OF 48X32 N ALTRX LINER AT NON CEMENTED INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. THE FEMORAL HEAD WAS DISPLACED SUPERIOR AND RUBBING THE SUPERIOR RIM OF THE CUP. AFTER EXPLANTING THE FEMORAL HEAD AND REMAINING LINER, THOROUGH WASHOUT/DEBRIDEMENT, AND CUP/STEM STABILITY/FIXATION CHECKED, A DM CONSTRUCT WAS DETERMINED TO BEST CORRECT POSSIBLE CAUSATIONS. HIP WAS REDUCED WITH A 48X41 DM LINER, 41X22.225 HEAD LINER, AND 22.225 METAL HEAD. STABILITY WAS SATISFACTORY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22496013 ↗
• InjuryJun 11, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION. SURGEON TOOK OUT THE 48 POROCOAT CUP/LINER AND 32 +5 HEAD AND REPLACED WITH A 54 GRIPTION MULTIHOLE, 54 DUAL MOBILITY LINER WITH A 47/28 OUTER/INNER HEAD. THE OTHER CUP WAS DISLOCATING AND THERE WAS NON-CEMENTED LOOSENING OF THE CUP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 22187306 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REMOVAL OF IMPLANTS DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21856941 ↗
• InjuryMar 11, 2025Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER WAS BROKEN DUE TO CUP POSITION AND IMPLANT IMPINGEMENT. THERE WAS LINER LOOSENING AT NON-CEMENTED INTERFACE. ALL PIECES WERE RETRIEVED. DOI: UNKNOWN, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21577531 ↗
• InjuryNov 12, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS THOUGHT THAT THE CUP MOVED AND WAS LOOSE. SURGICAL DELAY WAS UNKNOWN. DOI: ON (B)(6) 2015. DOR: ON (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20666348 ↗
• InjuryOct 4, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY VIA THA. IMPLANTS WERE IMPLANTED IN MOM STATE. AFTER THE SURGERY, THE CUP LOOSENED DUE TO ARMD, AND THE REVISION SURGERY WAS PERFORMED OR WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 20371508 ↗
• InjurySep 11, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  MARATHON INSERT LOOSENING, PAIN AND SQUEAKING. THIS IS THE SECOND REVISION OF THE LINNER, THE FIRST REVISION WAS 1 YEAR BEFORE (10 MONTHS AFTER THE FIST IMPLANTATION).

  Patient problems: Pain

  MAUDE report 20189053 ↗
• MalfunctionJun 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  WHEN FIXING THE ACETABULAR CUP, THE 25MM DRILL BIT DOES NOT FIT INTO THE PATIENT. DURING THE PROCEDURE, WHEN PLACING THE ACETABULAR CUP, A FRACTURE OF THE POSTERIOR ACETABULAR RIM IS EVIDENT, SO THE CUP LOSES ITS PRESSFIT; THE REAMING PROCESS MUST BE CARRIED OUT AGAIN. THE DRILL BIT BROKE BUT NO PART REMAINED IN THE PATIENT. THERE WAS NO HARM TO THE PATIENT AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 19536086 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 19019626 ↗
• InjuryFeb 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A CUSTOM DUAL MOBILITY IMPLANT SURGERY PERFORMED LAST WEEK AND HAS SINCE STARTED TO DISLOCATE. ON REVISION SURGEON FOUND THAT THE CUSTOM METAL LINER HAS DISSOCIATED FROM THE PINNACLE CUP. HE TRIED TO RESEAT IT BUT IT JUST KEPT JUMPING BACK OUT ON IMPACTION DESPITE BEING CORRECTLY LOCATED. THE 46MM CUP WAS LEFT INSITU AS VERSION AND INCLINATION WERE FINE. ISSUE WAS THAT THE CUSTOM METAL LINER KEPT RELEASING FROM THE CUP.

  Patient problems: Insufficient Information

  MAUDE report 18778504 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  J&J MD MIR SUBMISSIONS. MEDICAL AFFAIRS EMEA HAVE RECEIVED: A PATIENT RECEIVED A CORAIL PINNACLE HIP WITH CERAMIC ON CERAMIC ARTICULATION 1, 5 YEARS AGO. NOW PRESENTING INCREASED LEVELS OF COBALT,CROME AND TITANIUM IN BLOOD.

  Patient problems: Insufficient Information

  MAUDE report 18371774 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED E-MAIL. THE PATIENT SUFFERED INJURIES AS A RESULT OF A DEFECTIVE IMPLANT. LINK EXISTING RELATED (B)(4) RIGHT HIP TO CAPTURED THE REPORTED HARM PROVIDED IN THE MRR FINDINGS. THIS IS A REVIEW OF NON MOM MEDICAL RECORD RECEIVED. (B)(4) ON (B)(6) 2019, THE PATIENT HAD A REVISION RIGHT TOTAL HIP TO ADDRESS WORN ACETABULAR LINER WITH PARTIAL BREAKAGE. DURING THE SURGERY, THE SURGEON OBSERVED METALLOSIS, THE CERAMIC HEAD HAD SOME BLACKENED AREAS ON IT, THE POLY LINER HAD BROKEN (FRACTURED) AND WAS NOTED TO BE EXTREMELY WORN. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING POLY LINER, AND CEMENT FEMORAL HEAD. THE COMPONENTS THAT WERE REMOVED WERE DEPUY PRODUCTS AS WELL.

  Patient problems: Foreign Body Reaction

  MAUDE report 18356625 ↗
• MalfunctionDec 6, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO PATIENT CONSEQUENCE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275715 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT OPERATED PRIMARY AT A PRIVATE HOSPITAL IN (B)(6) 2020. SYMPTOMS STARTED IN (B)(6) 2023 JARRING NOISE. PATIENT UNDERWENT A REVISION OF THE CUP/LINER ON (B)(6) 2023. HEAD WAS WORN THROUGH THE LINER, AND HEAD MOVED AGAINST THE CUP, A LOT OF METALLOSIS. SURGEON TOOK OUT THE CUP AND INSERTED ANOTHER CUP NOT FROM DEPUY SYNTHES. THERE WAS NO SURGICAL DELAY

  Patient problems: Foreign Body Reaction

  MAUDE report 18246612 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SURGERY IS THIS PATIENT'S SECOND HIP REVISION SURGERY IN THE PAST NINE DAYS DUE TO INFECTION. DURING HER FIRST REVISION SURGERY, PERFORMED ON (B)(6), 2023, HER PRIMARY FEMORAL HEAD AND POLYETHYLENE LINER WERE REMOVED, AND HER HIP WAS THOROUGHLY IRRIGATED AND DEBRIDED. A REPLACEMENT FEMORAL HEAD AND A REPLACEMENT POLYETHYLENE LINER WERE THEN IMPLANTED. THIS MOST RECENT SURGERY WAS THE FIRST STAGE OF A TWO-STAGE REVISION PROCEDURE DUE TO THE SAME INFECTION. DURING THIS SURGERY, ALL OF THE PATIENT'S COMPONENTS WERE REMOVED. HER HIP WAS ONCE AGAIN THOROUGHLY IRRIGATED AND DEBRIDED. AN ANTIBIOTIC SPACER CONSTRUCT, WHICH INCLUDED A PROSTALAC CUP, STEM, AND FEMORAL HEAD, WAS THEN IMPLANTED. THERE WAS NO SURGICAL DELAY. DURING THE SECOND STAGE OF THE TWO-STAGE PROCEDURE, WHICH WILL OCCUR ONCE THE PATIENT IS INFECTION FREE, THE ANTIBIOTIC SPACER WILL BE REMOVED AND REPLACED BY FINAL HIP REVISION COMPONENTS. DOI(FOR CUP AND STEM): (B)(6), 2023 DOI (FOR LINER AND HEAD): (B)(6), 2023 DOR: (B)(6), 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17948382 ↗
• InjuryAug 21, 2023Use of Device Problem; Use of Device Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016, DATE OF EVENT: (B)(6) 2023, (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED).

  Patient problems: Joint Laxity

  MAUDE report 17585128 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN AND DISLOCATION. DOI: (B)(6) 2023 DOE: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17481956 ↗
• InjuryAug 8, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO THE LOOSENING OF THE CUP AT THE NON-CEMENTED INTERFACE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17481627 ↗
• InjuryJul 26, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER LEFT HIP REPLACED ALMOST A YEAR AGO WHERE A SUMMIT AND PINNACLE CUP WAS IMPLANTED. THIS PATIENT DID WELL INITIALLY BUT RECENTLY DISLOCATED HERE HIP SEVERAL TIMES. NO DATES GIVEN FOR WHEN THIS PATIENT DISLOCATED AND WAS REDUCED IN THE ER AND OR. THE DECISION WAS MADE TO REVISE THIS PATIENTS CUP AND IMPLANT A NEW CUP WITH LESS ANTEVERSION TO MAKE THIS CONSTRUCT MORE STABLE. SURGEON EXPLANTED THE PATIENTS ACETABULAR CUP, LINER, AND FEMORAL HIP BALL AND IMPLANTED A ZIMMER G7 CUP. THE LOTT #¿S FOR THE HIP BALL AND LINER WERE NOT LEGIBLE BECAUSE OF DAMAGE FROM DISLOCATION AND BEING EXPLANTED WITH OSTEOTOMES. THE SUMMIT STEM WAS LEFT IN. DOI: (B)(6) 2022. DOR:(B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17395737 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED BY SURGEON SOMETIME IN 2020 ACCORDING TO SURGEON THE PATIENT BEGAN TO EXPERIENCE STABILITY ISSUE IN THE LAST FEW MONTHS AND DISLOCATED TWICE. THE EXACT DATE OF DISLOCATIONS WAS NOT KNOWN. SURGEON REVISED HER HIP AND EXPLANTED THE 32MM FEMORAL HIP BALL, 48MM SECTOR CUP, AND 48MM X 32MM NEUTRAL LINER. THE SUMMIT STEM WAS LEFT IN SITU , THE PART NUMBER AND LOT NUMBER FOR THE SUMMIT STEM IS UNKNOWN. THE SURGEON IMPLANTED A ZIMMER ACETABULAR CUP WITH A DUAL MOBILITY LINER AND ACHIEVED GOOD STABILITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16627898 ↗