PINNACLE 1219-32-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295014058), received between Jan 22, 2018 and Jan 27, 2026 — classified as 30 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTED CONSTRAINED LINER FOR STABILITY. DOI: UNKNOWN . DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24193229 ↗
• InjuryJan 15, 2026Fracture

  PATIENT UNDERWENT REVISION SURGERY. THE LINER AND HEAD OF THE PATIENT WAS REPLACED. THE DOCTOR WAS STRUCK BY THE WEAR AND TEAR OBSERVED IN SUCH A SHORT PERIOD OF TIME.

  Patient problems: Insufficient Information

  MAUDE report 24080879 ↗
• InjuryJul 3, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL SURGERY ON AN UNKNOWN DATE IN 2019 TO HAVE A HIP JOINT INSTALLED. AFTER AWHILE, PATIENT WAS ADMITTED TO THE HOSPITAL WITH A HIP DISLOCATION IN AN EXTREME POSITION. DURING REVISION SURGERY, IT WAS REVEALED THAT THE INSERT AND THE HEAD WERE IDENTICALLY ERASED. IMPLANT WAS REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 22395258 ↗
• InjuryMar 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A POLYETHYENE RUPTURE IN A CORAIL PINNACLE TOTAL HIP PROTHESIS, POLY 52 FOR 32 +4 10 AFTER A TRAUMA.

  Patient problems: Insufficient Information

  MAUDE report 21609509 ↗
• InjuryOct 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED, THAT SURGEON PERFORMED A HEAD/LINER EXCHANGE ON A FORMER PATIENT. THE REASON FOR REMOVAL/ REVISION SURGERY WAS POLY WEAR. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20536520 ↗
• InjuryAug 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A LINER EXCHANGE FOR LATE DISLOCATION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2010, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20087348 ↗
• InjuryFeb 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON GAVE A CALL DIRECTLY TO COMPLAINT HANDLING UNIT: IMPLANTATION OF HIP-TEP RIGHT SIDE ON (B)(6) 2019. REVISION OF INLAY AND HIP HEAD ON (B)(6) 2023 AS INLAY DISASSOCIATED FROM CUP.

  Patient problems: Discomfort; Joint Laxity; Pain

  MAUDE report 16395752 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON COMPLETED A PRIMARY CORAIL/PINNACLE SURGERY IN (B)(6) 2017. IN (B)(6) 2020, THE ORIGINAL LINER DISSOCIATED FROM THE CUP AND THE FIRST REVISION SURGERY WAS PERFORMED BY ANOTHER SURGEON. THIS SURGERY CONSISTED OF A LINER CHANGE. DOI: (B)(6) 2017. DOR: (B)(6) 2020. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 14653912 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON COMPLETED A PRIMARY CORAIL/PINNACLE SURGERY IN(B)(6) 2017. IN (B)(6) 2020, THE ORIGINAL LINER DISSOCIATED FROM THE CUP AND THE FIRST REVISION SURGERY WAS PERFORMED BY ANOTHER SURGEON. THIS SURGERY CONSISTED OF A LINER CHANGE. IN (B)(6) 2022 THE LINER DISSOCIATED FROM THE CUP AGAIN. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6)2022 BY BOTH SURGEONS. THE ORIGINAL CUP WAS REMOVED AND A PINNACLE SECTOR CUP IMPLANTED WITH A NEW LINER. THE HEAD WAS ALSO REMOVED AND CHANGED. NO DELAY TO SURGERY. THE PATIENT HAS NOW HAD TO UNDERGO TWO REVISION SURGERIES. DOI: (B)(6) 2020. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Insufficient Information; Pain

  MAUDE report 14653237 ↗
• InjurySep 20, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE SURGEON PERFORMED A REVISION TOTAL HIP ARTHROPLASTY ON A PATIENT WHO HAD BEEN PLAYING SOCCER AND COMPLAINED OF A STRANGE INSTABILITY THAT BEGAN TO OCCUR DURING SOCCER. THE SURGEON EXPOSED AND FOUND THAT THE LINER HAD DISSOCIATED FROM THE SHELL. THE SURGEON NOTED THAT THE LINER SHOWED SIGNS OF DEFORMATION AND THE ARD TABS HAD SHEARED OFF. THE CERAMIC FEMORAL HEAD HAD VISIBLE STRIPE WEAR. THE SHELL WAS WELL-FIXED AND IN GOOD CONDITION. THE STEM WAS WELL-FIXED AND IN GOOD CONDITION. IF THE LINER HAD NOT DISASSOCIATED, THE STRIPE WEAR WOULD NOT HAVE OCCURRED. THE SURGEON THEN REMOVED THE DAMAGED HEAD AND LINER, WASHED AND IRRIGATED THE WOUND THOROUGHLY, AND PROCEEDED TO IMPLANT A NEW FEMORAL HEAD AND NEW LINER WHICH MATCHED THE SIZE OF THE PREVIOUS LINER. THE SURGERY FINISHED SUCCESSFULLY ACCORDING TO PLAN. DOI: UNKNOWN. DOR: (B)(6) 2021, UNKNOWN SIDE.

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

  MAUDE report 12495611 ↗
• InjuryJun 25, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  1. KINDLY PROVIDE IMPLANTS PRODUCT AND LOT CODE DETAILS OF (B)(6) 2016 EVENT. REF: 1219-32-152 LOT: C52640.. 2. AFFECTED SIDE OF THE HIP? RIGHT SIDE 3. PLEASE CONFIRM LOT 1219-32-152 LOT: 52640 WAS THE REPLACEMENT OF PINNACLE MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 28 MM ID 44MM OD, THAT IS NOT CORRECT, REF:1219-32-152 LOT: HM0230 WAS THE REPLACEMENT OF REF: 1219-32-152 LOT: C52640. IN ANY MOMENT OF THIS EVENT MARATHON POLYETHYLENE ACETABULAR LINER +4 10 DEGREE 28MMID 44MMOD WAS USED. 4. KINDLY CONFIRM HOW MANY LINERS WERE INVOLVED SINCE QUANTITY INVOLVED AND QUANTITY TO BE REPLACE WERE ANSWERED 2. TWO INVOLVED AND TWO REPLACED: LINER AND FEMORAL HEAD 5. KINDLY PROVIDE WHAT WAS THE IMPLANTED LINER AND EXPLANTED LINER SINCE EVENT DESCRIPTION MENTIONED PINN MAR +4 10D 28IDX44OD WHILE THE IP REPORTED PINN MAR +4 10D 32IDX52OD. REF:1219-32-152 LOT: HM0230 WAS THE REPLACEMENT OF REF: 1219-32-152 LOT: C52640. 6. PRODUCT DETAILS OF THE EXPLANTED HEAD. BIOLOX DELTA CERAMIC FEMORAL HEAD +5.0 32MM DIA 12/14 TAPER (REF: 1365-32-320 LOT: 8234446) DUE TO THE NATURE OF THE REPORTED EVENT, AND IN ACCORDANCE WITH OUR PROCEDURES, WE ARE REQUIRED TO REQUEST THE FOLLOWING INFORMATION TO A

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

  MAUDE report 12067266 ↗
• InjuryMay 14, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY. AFFECTED SIDE WAS THE LEFT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Joint Dislocation; Joint Laxity; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 11825469 ↗
• InjuryMar 25, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION OF PINNACLE INSERT. INSERT WAS DISLOCATED FROM SHELL WITH OBVIOUS WEAR. LIKELY CAUSE IMPINGEMENT.

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

  MAUDE report 11570226 ↗
• InjurySep 30, 2020Fracture; Device Dislodged or Dislocated; Noise, Audible; Fracture; Device Dislodged or Dislocated; Noise, Audible

  A PATIENT WAS TREATED WITH A HIP TEP IMPLANTATION IN 2017 AND NOW COMPLAINED ABOUT SUDDEN RESTRICTION OF RANGE OF MOVEMENT AND A SQUEAKING SOUND IN THE LEFT HIP JOINT. INTRA OP X-RAY SHOWS AN ECCENTRIC PLACEMENT OF THE HIP HEAD AND A SUBLUXATED INLAY WITH EXPECTED PRE-DAMAGE. X-RAY POST OP INCONSPICUOUS.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10606992 ↗
• InjurySep 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED THAT THE AFFECTED SIDE WAS THE LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10482497 ↗
• InjuryMay 20, 2020Device-Device Incompatibility; Device Dislodged or Dislocated; Naturally Worn; Device-Device Incompatibility; Device Dislodged or Dislocated; Naturally Worn

  TOTAL NON-CEMENETATED HIP PROSTHESIS, IMPLANTED 4 YEARS AGO ((B)(6) 2016), REVIEWED FOR THE POSSIBILITY OF WEAR OF POLYETHYLENE AND WHICH IS FINALLY A DISSOCIATION OF POLYETHYLENE.

  Patient problems: No Code Available

  MAUDE report 10074907 ↗
• InjuryApr 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR RECURRENT DISLOCATION. IT WAS ALSO REPORTED THAT X-RAY FOUND THAT THE PATIENT HAD A SIGNIFICANT POSITIONING OF THE LEFT HIP. OPERATIVE NOTES REPORTED THAT THERE WAS A FRACTURED PART ON THE TIP OF THE GREATER TROCHANTER. THE FRACTURE FRAGMENT WAS CAUGHT WITH MERSILENE TAPE SEVERAL TIMES AND IT WAS THEN PULLED DOWN AROUND THE GREATER TROCHANTER. IT WAS OBSERVED THAT THE HIP JOINT WAS POSITIONING EASILY AND IT WAS DISLOCATING ANTERIORLY. SCAR TISSUES WAS MAKING A LEVER TO THE FEMORAL NECK, AND IT WAS HELPING ANTERIOR DISLOCATION. DOI: (B)(6) 2007; DOR: (B)(6) 2007; LEFT HIP.

  Patient problems: Adhesion(s); Joint Dislocation; No Code Available

  MAUDE report 9915807 ↗
• InjuryFeb 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REPORTED TO (B)(4): "ATRAUMATIC DISLOCATION OF THE INLAY WITH LOOSENING FROM THE CUP AFTER HIP SPORT".

  Patient problems: No Code Available; Pain

  MAUDE report 9670958 ↗
• InjuryJul 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CUSTOMER IS REPORTING A DISASSOCIATION OF PE-INLAY FROM CUP. LEFT SIDE. DOI: (B)(6) 2018, DOR: (B)(6) 2019. A SURGERY DELAY WAS NOT REPORTED.

  Patient problems: No Code Available

  MAUDE report 8772620 ↗
• InjuryJul 2, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT POLY WEAR WAS THE REASON FOR REVISION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8753096 ↗
• InjuryMay 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8621458 ↗
• InjuryApr 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8565230 ↗
• InjuryNov 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 8085810 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES FRACTURE BONE. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP PAIN. REVISION NOTES STATED THAT THE CUP, HEAD, AND LINER WERE REMOVED DURING REVISION.THE CUP WAS REMOVED DUE TO LOOSENING. DOI: (B)(6) 2005 - DOR: (B)(6) 2009 (RIGHT HIP) FIRST REVISION.

  Patient problems: Not Applicable; Pain

  MAUDE report 7901656 ↗
• InjuryMay 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE PLAINTIFF PROFILE FORM AND STICKER SHEET RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. STICKER SHEET SHOWED THAT THERE WAS A REVISION WHERE THE HEAD WAS REVISED WITH UNKNOWN REASON. DOI: (B)(6) 2012; DOR: (B)(6) 2012; RIGHT HIP. (B)(6).

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7552592 ↗