PINNACLE 1219-36-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295014492), received between Feb 26, 2020 and May 8, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RECEIVED A CORAIL/PINNAL HIP AT HOSPITAL ON (B)(6) 2020. IMPLANTED: CUP PINNACLE: 62, INSERT: 62/36 POLY, STEM: CORAIL KHO 14, HEAD: 36 CERAMIC +8.5MM. PATIENT GOT UP ON (B)(6) 2025 AND HEARD A SQUEAKING SOUND FROM HIS HIP. THE PATIENT THEN WENT TO THE HOSPITAL, WHERE IT TURNED OUT THAT THE LINER WAS DISLOCATED, COMPLETELY TILTED 90 DEGREES AND THE ARD TAGS WERE COMPLETELY DEFORMED. REVISION WAS PERFORMED. HOSPITAL STATES THAT IT HAD PREVIOUSLY SEEN THIS PROBLEM IN A PATIENT WITH THE SAME SIZE LINER/CUP.

  Patient problems: Insufficient Information

  MAUDE report 21985998 ↗
• InjuryJan 12, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  REVISION OF ACETABULAR INSERT. AFTER ALMOST TWO YEARS FROM FIRST IMPLEMENTATION ARD (ANTI ROTATIONAL DEVICE) SCALLOPS ON THE CUP ARE DAMAGED TOO EARLY.FROM THE HOSPITAL WE RECEIVED COMPLAINT THAT SCALLOPS ARE WORN OUT TOO EARLY.

  Patient problems: Insufficient Information

  MAUDE report 18502484 ↗
• InjuryApr 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD CORAIL AND PINNACLE IMPLANTED IN (B)(6) 2022 AT ANOTHER FACILITY, SUBSEQUENTLY HAD SPINAL FUSION AND HAS DISLOCATED TWICE AND ALSO SHOWN SIGNS OF INFECTION AROUND THE JOINT AND DISTAL FEMORAL IMPLANT. THIS REQUIRED REVISION SURGERY TO REMOVE THE IMPLANT AND REPLACE WITH CORAIL REVISION STEM AND CEMENTED BIMENTUM CUP. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: XRAYS, REVISION SURGERY, IS THE PATIENT PART OF A CLINICAL STUDY: NO, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (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: Joint Dislocation; Unspecified Infection

  MAUDE report 16806468 ↗
• InjuryMar 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT IS TO CAPTURE THE REPORT OF "PREVIOUS REVISION OF PRIMARY LINER TO CONSTRAINED LINER WAS ON (B)(6) 2021" IDENTIFIED ON LINKED COMPLAINT (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 13770744 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10868403 ↗
• InjuryFeb 26, 2020Off-Label Use; Off-Label Use

  CLAIM LETTER RECEIVED ALLEGING PAIN, INABILITY TO WALK WITHOUT CRUTCHES, INABILITY TO MOVE, TROUBLE SLEEPING, SPASMS, DISCOMFORT, SUFFERING, SIGNIFICANT LOSS OF AMENITY. DOI: (B)(6) 2017 - DOR: (B)(6) 2018 (RIGHT HIP). EMAIL NOTIFICATION FROM (B)(6) RECEIVED ALLEGING INFECTION. PRIMARY SURGERY DATE HAS BEEN UPDATED TO (B)(6) 2015 AND REVISION DATE TO (B)(6) 2016. THE REVISION ON (B)(6) 2017 NOTED ON THE KENNEDYS APPENDIX B MATCHES WITH THE SECOND STAGE REVISION MENTIONED ON THE ORIGINAL CLAIM LETTER. IT WAS INDICATED THAT DURING THIS DATE, THE INFECTION HAD SETTLED AND THE CLIENT'S HIP WAS NOW PUT BACK IN PLACE. IT IS UNKNOWN IF THE DEFINITIVE IMPLANTS ARE FROM DEPUY. IT SHOULD BE NOTED THAT AROUND TEN DAYS AFTER THE DEFINITIVE'S WERE IMPLANTED, THE PATIENT HAD EXPERIENCED PAIN AGAIN. IT WAS ALSO INDICATED THAT THIS CLAIM IS NOT ACTIVELY LITIGATED. DOI: (B)(6) 2015 - DOR: (B)(6) 2016 (RIGHT HIP).

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Muscle Spasm(s); No Code Available; Pain; Unspecified Infection

  MAUDE report 9757323 ↗