PINNACLE POROCOAT 1217-22-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 10603295009825), received between Mar 9, 2017 and Sep 10, 2026 — classified as 304 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (51 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 335 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a THA revision was performed for a disassociated liner after the patient had fell down while playing pickle ball. The patient was about 3 year post-op on the day of the revision. After exposure and dislocation of the hip, and removal of the femoral head, the surgeon inspected the liner. The liner (Altrx 36/52 +4 / 10 degrees) was not really disassociated but rather had broken into a few pieces. The elevated portion of the liner (the 10 degree lip) had broken off, as well as some of the ARDs.The stem in situ is a Corail KLA size 13. The femoral head had been rubbing directly against the cup for some time, so there was some intra-articular debris. The surgeon opted to remove the cup and upsize to a size 54. He used an Emphasys multi-hole and elevated rim liner. He then used a TS Delta ceramic head size 40+5. The Corail stem was well fixed and remained in situ. The post x-rays were satisfactory and the patient is in good condition.

  Patient problems: Fall

  MAUDE report 50714410 ↗
• InjuryAug 31, 2026Noise, Audible

  Patient problems: Foreign Body Reaction; Pain; Unspecified Musculoskeletal problem

  MAUDE report 50518546 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY DUE TO EHLERS-DANLOS SYNDROME, DYSPLASTIC AND DEGENERATIVE RIGHT HIP. ON (B)(6) 2025, PATIENT UNDERWENT A REVISION, RIGHT TOTAL HIP ARTHROPLASTY DUE TO PAIN, METAL ON METAL WEAR WITH ELEVATED METAL ION LEVELS PRIOR SPINAL FUSION. DOI: (B)(6) 2010, DOR: (B)(6) 2025, AFFECTED SITE: RIGHT HIP. THE RELATED (B)(4) CAPTURES REVISION OF THE LEFT HIP DUE TO ELEVATED IONS AND PERSISTENT PAIN.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 25006640 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT ACETABULAR COMPONENT WAS REVISED DUE TO GROIN PAIN. NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 24833502 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A PINNACLE LINER THAT HAD ACCELERATED WEAR AND/OR DISENGAGEMENT OF THE LOCKING MECHANISM. THIS LED TO AN ECCENTRIC HEAD POSITION IN THE SHELL. DOCTOR DECIDED TO REMOVE EXISTING PINNACLE SHELL AND LINER AND REPOSITION A NEW CUP. IT WAS STATED THAT PINNACLE LINER WAS LOOSE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24799730 ↗
• InjuryFeb 17, 2026Use of Device Problem

  IT WAS REPORTED THAT SURGEON EXPLANTED A PINNACLE CUP AND LINER THAT HE DETERMINED NEEDED TO BE MORE MEDIAL. AFTER EXPLANTING THE CUP AND THE HEAD, WE REAMED WITH A 49MM REAMER TO MEDIALIZE CUP POSITION. A 50MM PINNACLE GRIPTION CUP WAS IMPLANTED WITH 2X 25MM SCREWS, A 50/43 DM LINER AND A 43/22+4 BI-MENTUM HEAD CONSTRUCT. STABILITY WAS SATISFACTORY AND GOOD ROM WAS OBSERVED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24364966 ↗
• InjuryJan 8, 2026Migration

  IT WAS REPORTED THAT ORIGINAL CUP WENT THROUGH THE WALL OF THE ACETABULUM. AFFECTED SIDE- LEFT HIP.

  Patient problems: Bone Notching

  MAUDE report 24003673 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23926216 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23921616 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION LEFT ACETABULUM DUE TO INSTABILITY. ORIGINAL DOS: (B)(6) 2023. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23887626 ↗
• InjuryDec 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING. SURGEON DETERMINED THAT THE PATIENTS CUP WAS MALPOSITIONED AND OPTED TO REVISE THE ACETABULUM. THE ORIGINAL CUP, LINER, AND 32 CERAMIC HEAD WERE REMOVED AND REPLACED WITH A REVISION CUP FROM ANOTHER MANUFACTURER. A TRIAL REDUCTION WAS PERFORMED WITH 40MM +12 HEAD AND THE HIP WAS STABLE. A 40MM +12 TS CERAMIC HEAD WAS OPENED AND IMPLANTED. STABILITY OF THE HIP WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL: YES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23730350 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. DOI- UNKNOWN . DOR- (B)(6) 2025. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23622245 ↗
• InjuryNov 13, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PINNACLE LINER WAS REVISED DUE TO LUXATION OUT OF THE PINNACLE CUP. ONE PIECE HAS BROKEN OFF. HEAD HAS BEEN ARTICULATING AGAINST THE CUP FLOOR.

  Patient problems: Insufficient Information

  MAUDE report 23546997 ↗
• InjuryNov 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION HIP SURGERY BECAUSE THE PINNACLE MARATHON LINER SEEMED TO HAVE BROKEN WHICH LEAD TO THE METAL FEMORAL HEAD RUBBING AGAINST THE METAL CUP. THE CUP, LINER AND HEAD WERE ALL CHANGED AND THE STEM WAS RETAINED WITH NO DAMAGE TO IT.

  Patient problems: Insufficient Information

  MAUDE report 23452570 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE DOCTOR WAS POSITIONING THE IMPLANT ON THE BONE, HE ACCIDENTALLY STRUCK IT WITH A MALLET, RESULTING IN PART OF THE IMPLANT BEING DAMAGED. SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ADDITIONAL SUPPLIES FROM HOSPITAL INVENTORY. FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700092 ↗
• InjuryJul 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE POLY SHOWED DAMAGED FROM IMPINGEMENT POSTERIORLY. PATIENT ALSO EXPERIENCED DISLOCATION. REVISION WAS PERFORMED. REVISED TO A DUAL MOBILITY AND CHANGED THE CUP POSITION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22628737 ↗
• InjuryJul 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CUP REVISION FOR MALPOSITION. SURGEON DID NOT REVISE STEM JUST PULLED CUP AND HEAD. NO ALLEGATION AGAINST LINER. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22479759 ↗
• InjuryJul 3, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THE PATIENT ORIGINALLY HAD A PINNACLE CUP AND SROM STEM IMPLANTED APPROXIMATELY THIRTY (30) YEARS AGO. AFTER THE PATIENT EXPERIENCED TRAUMA, THE FEMORAL HEAD BROKE THROUGH THE CUP/LINER AND THE PATIENT UNDERWENT AN ACETABULAR REVISION. THE SURGEON NOTED THAT PREVIOUS UNTREATED TRAUMA AND OTHER COMORBIDITIES CONTRIBUTED TO THE DAMAGE TO THE HIP AND NEED FOR THE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 22394172 ↗
• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE POLYETHYLENE LINER DISLOCATED FROM THE SHELL. A REVISION PROCEDURE TO CORRECT THE JOINT WILL BE REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 22359042 ↗
• InjuryJun 18, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE CUP SPUN OUT AND ENDED UP VERTICAL. SURGEON REMOVED THE CUP, SCREW, LINER, AND HEAD AND IMPLANTED A NEW GRIPTION MULTI-HOLE CUP, SCREWS, LINER, AND REVISION TS HEAD. THERE WERE NO KNOWN SURGICAL DELAYS. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22286138 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A VERY BAD INFECTION. SURGEON REMOVED THE CONSTRUCT AND PUT IN AN ANTIBIOTIC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22105943 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A GROWING PAIN AND APPEARANCE OF LOSENCY RADIOGRAPHICALLY AND ON A BONE SCAN. DOI: (B)(6) 2023,DOR: (B)(6) 2025,AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21970349 ↗
• MalfunctionApr 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2025 DUE TO ASEPTIC NECROSIS OF THE FEMORAL HEAD. DURING THE SURGERY, THE LINER WAS BROKEN. THE LINER WAS NOT MATCHING THE SIZE OF THE CUP, AND IT FRACTURED AT THE EDGE DURING THE SECOND ATTEMPT TO ADJUST ITS POSITION FOR IMPLANTATION. THE LINER COULD NOT BE REMOVED FROM THE PATIENT SEPARATELY, FINALLY IT WAS REMOVED TOGETHER WITH THE CUP. THE SCRATCHES ON THE CUP WERE CAUSED DURING THE EXTRACTION EFFORTS. ALL THE FRAGMENTS WERE RETRIEVED AND CLEARED. CHANGED ANOTHER LARGER SIZED LINER AND CUP TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED FOR ABOUT 1 HOUR. THE PATIENT WAS IN A STABLE CONDITION AND NO FURTHER ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936400 ↗
• InjuryApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PINNACLE POROCOAT WAS NOT REVISED, BUT THE MARATHON NEUTRAL LINER AND BIOLUX DELTA CERAMIC HEAD WERE REVISED DUE TO THE LINER HAVING FLIPPED OUT OF THE CUP. INITIAL SURGERY WAS DONE IN (B)(6) 2017.

  Patient problems: Insufficient Information

  MAUDE report 21881160 ↗
• InjuryMar 26, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT HAD A THA AND HAD LOOSENING OF THE ACETABULAR CUP AT NON-CEMENTED INTERFACE. THE HEAD, CUP, LINER AND SCREW WERE REMOVED. A 54 MULTIHOLE CUP WAS PLACED. THERE WAS NO INFECTION, NO BROKEN EQUIPMENT WAS REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21700662 ↗