PINNACLE 1219-32-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10603295013907), received between Jul 12, 2017 and Jul 30, 2026 — classified as 58 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Fracture; Device Dislodged or Dislocated

  It was reported that patient had a revision hip procedure through a direct lateral approach. The original hip replacement procedure with Pinnacle Trilock implants was completed 7 years previously. The patient had presented in AE with a two day history of pain, and reported hearing a ¿clunk¿ sound. The revision procedure involved the extraction of a Pinnacle Sector Cup 52mm, a Poly 52/32mm, and a 32mm ceramic head.

  Patient problems: Pain

  MAUDE report 50083530 ↗
• InjuryDec 30, 2025Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 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 FOR DISLOCATION. THE NON-ARTICULAR SURFACE OF THE REVISED POLYETHYLENE ACETABULAR LINER SHOWS MINOR YELLOWING.

  Patient problems: Joint Dislocation

  MAUDE report 23924605 ↗
• InjuryNov 13, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  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 23546987 ↗
• InjuryOct 3, 2025Break; Fracture; Device Dislodged or Dislocated; Break; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CEMENTLESS TOTAL HIP REPLACEMENT ON (B)(6) 2018. A HIGH-QUALITY BEARING PAIR WITH A CERAMIC HEAD AND CROSS-LINKED POLYETHYLENE WAS USED. RADIOLOGICAL EXAMINATION REVEALED THAT THE FEMORAL HEAD ARTICULATED DIRECTLY WITH THE METAL CUP, SUGGESTING EITHER WEAR OR DISLOCATION OF THE INLAY. DURING REVISION ON (B)(6) 2025, THE INLAY WAS FOUND TO BE PARTIALLY DISLOCATED FROM THE CUP (ROTATED APPROXIMATELY 90°). A SMALL EDGE OF THE INLAY HAD BROKEN OFF. WHETHER THIS SMALL EDGE BROKE OFF PRIMARILY OR SECONDARILY IS NOT KNOWN. COMPONENT FAILURE AFTER 7 YEARS. THE PATIENT ALSO HAS A LUMBAR SPINE FUSION. HOWEVER, INTRAOPERATIVE EXAMINATION REVEALED NO EVIDENCE OF IMPINGEMENT OF THE CONE AGAINST THE CUP OR INLAY. THE CERAMIC HEAD WAS INTACT WITH BLACK ABRASION MARKS. THE CUP WAS LEFT IN PLACE, AND A NEW INLAY + REVISION HEAD WAS INSERTED.

  Patient problems: Insufficient Information

  MAUDE report 23211634 ↗
• InjuryJul 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PE INLAY HAS DISLOCATED FROM THE ACETABULAR COMPONENT. THIS AFFECTED THE LEFT HIP JOINT.

  Patient problems: Insufficient Information

  MAUDE report 22588358 ↗
• 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 2017.

  Patient problems: Insufficient Information

  MAUDE report 21881163 ↗
• InjuryJan 29, 2025Naturally Worn; Naturally Worn

  THE PATIENT HAD A HEAD AND LINER EXCHANGE. HEAD WAS RIDING SUPERIOR WITH POLY WEAR. NO DELAY IN CASE. NO ADVERSE CONSEQUENCES. HEAD WAS NOT DAMAGED; POLY WAS DAMAGED FROM WEAR. DOI: (B)(6) 2011. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 21263472 ↗
• InjuryOct 3, 2024Fracture; Fracture

  PATIENT HAD PRIMARY HIP ARTHROPLASTY SURGERY ON (B)(6) 2015. HE UNDERWENT THE FIRST REVISION OF HIP ARTHROPLASTY WITH COMPONENT REPLACEMENT ON (B)(6) 2024 DUE TO DIFFICULTY WALKING AND PAIN. PRODUCT WAS NOTED AS CRACKED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20362066 ↗
• InjuryOct 2, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT HAS C-STEM PINNACLE IN PLACE WHERE THE INDEX PROCEDURE WAS CARRIED OUT ON (B)(6) 2019. PATIENT STATED SHE WAS AT HOSPITAL IN JULY 2024 WHEN SHE STEPPED STRANGELY AND FELT A CLUNK, AND HAD FELT DIFFERENT EVER SINCE. PATIENT HAD BEEN SEEN AND X-RAY DONE ON (B)(6) 2024, WHICH DEMONSTRATED NO ISSUES. AFTER ADVISING OF THIS INCIDENT SHE WAS SENT FOR ANOTHER X-RAY ON (B)(6) 2024, WHICH SHOWED THE LINER HAD BEEN COMPROMISED. THE POLY LINER WAS FRACTURED. REVISION SURGERY OCCURRED (B)(6) 2024

  Patient problems: Insufficient Information

  MAUDE report 20352411 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEM AND LINER WERE REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 19980848 ↗
• InjuryJul 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF LINER AT HOSPITAL. LINER AND FEMORAL HEAD REMOVED FROM THE PATIENT AND REPLACED. REASON FOR REVISION: PATIENT ORIGINALLY PRESENTED TO AN OUTPATIENT CLINIC DUE TO DISCOMFORT IN HIP. IDENTIFIED THAT THE LINER HAD BECOME DISENGAGED WITH THE CUP. ORIGINAL SURGERY WAS IN 2013. INTRA-OP NOTES: SURGEON NOTED THAT THE LINER HAD COME AWAY FROM THE CUP COMPLETELY, THERE WAS A FAIR AMOUNT OF BLACK TISSUE REMOVED FROM THE REGION AROUND THE ACETABULUM AND THIS COULD ALSO BE SEEN ON THE CUP.

  Patient problems: Discomfort; Foreign Body Reaction

  MAUDE report 19826427 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Pain

  MAUDE report 19711233 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT AND DEBRIDEMENT OF A CORAIL PINNACLE CONSTRUCT. HEAD AND LINER WERE REMOVED AND THE SIDE WAS THOROUGHLY CLEANED AND DEBRIDED. STEM AND CUP WERE NOT REMOVED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 18731064 ↗
• InjuryDec 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD CORAIL PINNACLE IMPLANTED (B)(6) 2023. SINCE THEN, PATIENT HAS REPEATEDLY DISLOCATED. AS A RESULT SURGEON, SELECTED TO REVISE THE CONSTRUCT TO PINNACLE DUAL MOBILITY. CORAIL STEM AND PINNACLE GRIPTION SHELL REMAINED. FEMORAL HEAD AND POLYETHYLENE LINER WERE EXCHANGED.

  Patient problems: Joint Dislocation

  MAUDE report 18310810 ↗
• InjuryNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REQUIRED HIP ACETABULAR REVISION. IN SITU IMPLANTS WERE IDENTIFIED AS DISLODGED ON X-RAY. SURGEON SURMISED LIKELY DISLOCATION WAS CAUSE BY IMPROPER PLACEMENT ON INITIAL SURGERY. SURGEON HAD TO CLEAR MAJOR METALOSIS FROM JOINT SPACE AND ACETABULAR REGION PRIOR TO REVISING THE JOIN WITH PDM.

  Patient problems: Foreign Body Reaction; Joint Dislocation

  MAUDE report 18143090 ↗
• InjurySep 5, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED AS THE ARD TABS GOT BROKEN OFF THE LINER, RESULTING IN A SPIN OUT. THERE WAS NON-CEMENTED LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2012. DOR:(B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17682821 ↗
• InjuryMay 3, 2023Fracture; Fracture

  SALES REP IS REPORTING A REVISION OF A PINNACLE PE INLAY BECAUSE OF FRACTURE. DOI: (B)(6) 2022, DOR: (B)(6) 2023, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16860248 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUERY INFECTION AND SURGEON DECIDED TO TAKE THE IMPLANTS OUT THAT WHERE IN SITU IN 2018. DOI: (B)(6) 2018; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15959874 ↗
• InjuryDec 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WITH RHEUMATOID ARTHRITIS WHO UNDERWENT PRIMARY ARTHROPLASTY OF THE RIGHT HIP DUE TO HIP ARTHROSIS. FIVE YEARS LATER, SHE WAS SUBMITTED TO ARTHROPLASTY REVISION DUE TO SUSPECTED LOOSENING OF THE UNCEMENTED POLYETHYLENE.

  Patient problems: Insufficient Information

  MAUDE report 15941910 ↗
• InjuryJul 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FEMALE; LEFT SIDE; 78YRS. REVISION OF A PINNACLE LINER. THE PATIENT HAD A THR ABOUT THREE WEEKS AGO FOR A NOFF (NECK OF FEMUR FRACTURE). THE REASON FOR REVISION WAS DUE TO MULTIDIRECTIONAL INSTABILITY, AND THE PATIENT HAD DISLOCATED 3X SINCE THEN. UPON EXPOSURE THE SURGEON NOTED THAT THE FEMORAL STEM (STRYKER, EXTER STEM) WAS IMPLANTED IN A RETROVERTED POSITION. THE SURGEON SAID THAT THIS WOULD HAVE ATTRIBUTED TO THEIR POSTERIOR INSTABILITY. THE PINNACLE CUP WAS LEFT IN SITU, AND THE PINNACLE 32/52 NEUTRAL LINER 1219-32-052 WAS EXPLANTED. A PINNACLE REVISION LINER WAS THEN IMPLANTED 1218-32-652.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15085271 ↗
• InjuryJun 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REPORTED ON 15TH MARCH 2022; THE PATIENT HAD RIGHT HIP ARTHROPLASTY SURGERY IN (B)(6) 2021. AFTER APPROXIMATELY TWO MONTHS, THE PATIENT REPORTED HEARING A ¿CLICK¿ BUT CONTINUED TO WALK ON THE HIP WITHOUT SEEKING HELP AT THAT TIME. THE PATIENT THEN COMPLAINED THAT THE HIP WAS ¿SQUEAKING¿ AND SORE AND SOUGHT HELP. THERE WAS EVIDENCE OF METALLOSIS SHORTLY AFTER SKIN INCISION, THE ACETABULAR LINER HAD DISLOCATED FROM THE ACETABULAR SHELL AND THE CERAMIC HEAD SHOWED SIGNIFICANT WEAR. THE PROCEDURE WAS MADE CONSIDERABLY MORE COMPLICATED AS THE HEAD WAS REPORTEDLY ¿STUCK¿ IN THE LINER AND IT WAS DIFFICULT TO DISLOCATE THE HIP. IT WAS NECESSARY TO USE A SAW TO MAKE A CUT ON THE LINER FOR THE PURPOSE OF LEVERING THE LINER TO DISLOCATE THE HIP AND REMOVE THE HEAD. NEW INFORMATION AS OF TODAY 27TH MAY 2022: THE PATIENT WAS ¿DOING WELL¿ AT THE SIX-WEEK POST OPERATIVE CHECK-UP ACCORDING TO THE PHYSICIANS NOTES, BUT WITHIN A WEEK, PRESENTED AT CLINIC REPORTING A ¿CLICKING AND GRINDING¿ SOUND AND SENSATION, BUT NO PAIN. A REPEAT X RAY SHOWED THAT THE LINER HAD DISASSOCIATED, REASON UNKNOWN. THE PHYSICIANS¿ NOTES SUGGEST THAT THERE MAY BE SOME ¿ISSUE WITH THE LOCKING MECHANISM OF THE LINER INTO TH

  Patient problems: Foreign Body Reaction

  MAUDE report 14685205 ↗
• InjuryApr 7, 2022Naturally Worn; Naturally Worn

  PATIENT HAD TOTAL HIP REPLACEMENT SURGERY IN (B)(6) 2020. PATIENT CHECK X-RAY IN (B)(6) 2021 SHOWED CORRECT ANATOMICAL PLACEMENT OF THE SHELL AND LINER. THE PATIENT REPORTED A ¿JOLT¿ TO THE HIP IN (B)(6) 2022, AND FURTHER DESCRIBED THIS AS HAVING ¿TURNED THE LEG INTO AN UNUSUAL POSITION WHICH RESULTED IN PAIN¿. PATIENT COMPLAINTS OF PAIN DURING AMBULATION. THERE WAS EVIDENCE OF SOME METALLOSIS SHORTLY AFTER SKIN INCISION, THE ACETABULAR LINER HAD NOT DISLOCATED FROM THE ACETABULAR SHELL AND THE CERAMIC HEAD SHOWED SIGNIFICANT WEAR. IT WAS NECESSARY TO USE A SAW TO MAKE A CUT ON THE LINER FOR THE PURPOSE OF LEVERING THE LINER TO DISLOCATE THE HIP AND REMOVE THE HEAD. THE CONSULTANT EXAMINED THE LINER AFTER REMOVAL AND FELT THE WALL OF THE LINER HAD BEEN WORN CONSIDERABLY AND ¿HAD THINNED¿.

  Patient problems: Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 14039920 ↗
• InjuryMar 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD RIGHT HIP ARTHROPLASTY SURGERY IN JUNE 2021. AFTER APPROXIMATELY TWO MONTHS, THE PATIENT REPORTED HEARING A ¿CLICK¿ BUT CONTINUED TO WALK ON THE HIP WITHOUT SEEKING HELP AT THAT TIME. THE PATIENT THEN COMPLAINED THAT THE HIP WAS ¿SQUEAKING¿ AND SORE AND SOUGHT HELP. THERE WAS EVIDENCE OF METALLOSIS SHORTLY AFTER SKIN INCISION, THE ACETABULAR LINER HAD DISLOCATED FROM THE ACETABULAR SHELL AND THE CERAMIC HEAD SHOWED SIGNIFICANT WEAR. THE PROCEDURE WAS MADE CONSIDERABLY MORE COMPLICATED AS THE HEAD WAS REPORTEDLY ¿STUCK¿ IN THE LINER AND IT WAS DIFFICULT TO DISLOCATE THE HIP. IT WAS NECESSARY TO USE A SAW TO MAKE A CUT ON THE LINER FOR THE PURPOSE OF LEVERING THE LINER TO DISLOCATE THE HIP AND REMOVE THE HEAD. DOI: JUN 2021, DOR: (B)(6) 2022, RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction

  MAUDE report 13965454 ↗
• InjuryMar 30, 2022Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  REVISION COMPLETED DUE TO PAIN AND AUDIBLE SOUND DURING AMBULATION. THE PATIENT THEN COMPLAINED THAT THE HIP WAS ¿SQUEAKING¿ AND SORE AND SOUGHT HELP. THERE WAS EVIDENCE OF METALLOSIS SHORTLY AFTER SKIN INCISION, THE ACETABULAR LINER HAD DISLOCATED FROM THE ACETABULAR SHELL AND THE CERAMIC HEAD SHOWED SIGNIFICANT WEAR. THE PROCEDURE WAS MADE CONSIDERABLY MORE COMPLICATED AS THE HEAD WAS REPORTEDLY ¿STUCK¿ IN THE LINER AND IT WAS DIFFICULT TO DISLOCATE THE HIP. IT WAS NECESSARY TO USE A SAW TO MAKE A CUT ON THE LINER FOR THE PURPOSE OF LEVERING THE LINER TO DISLOCATE THE HIP AND REMOVE THE HEAD. DOI: (B)(6) 2021; DOR: (B)(6) 2022; RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction

  MAUDE report 13950745 ↗
• InjurySep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT IS INDICATED THE PATIENT UNDERWENT A PRIMARY LEFT HIP ARTHROPLASTY WITH IMPLANTATION OF DEPUY PRODUCTS. IMPLANTED PRODUCTS ARE FOUND ON PAGE 1 OF THE ATTACHED MEDICAL INFORMATION. IT IS INDICATED ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION DUE TO LEFT HIP DISASSOCIATION OF THE CUP AND LINER, POSSIBLE INFECTION, AND DETECTION OF POLYETHYLENE AND METAL ABRASION. THE CERAMIC HEAD AND POLY LINER WERE REVISED. POST-OPERATIVE MICROBIOLOGY REPORTS INDICATED NO EVIDENCE OF INFECTION. OPERATIVE NOTE NOT AVAILABLE AT THE TIME OF REVIEW. EVENT IS CAPTURED ON (B)(4). A SECOND REVISION OCCURRED ON (B)(6) 2021 TO ADDRESS DISASSOCIATION OF THE CUP AND LINER, PAIN, AND GRINDING. PRODUCT INFORMATION CAN BE FOUND ON PAGE 1 OF THE ATTACHED MEDICAL RECORDS. OPERATIVE NOTE NOT AVAILABLE AT THE TIME OF REVIEW. EVENT IS CAPTURED ON (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12432425 ↗