PINNACLE 1219-32-448Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295014317), received between Aug 18, 2017 and Jun 11, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD DISLOCATING THA. REVISED TO +4 10° LINER AND LONGER HEAD. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25472069 ↗
• InjuryJan 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING AND LINER WAS REMOVED AND REPLACED WITH A CONSTRAINED LINER. THERE WAS NO LOSS OF TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21143955 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2024. THE STEM, HEADBALL AND LINER WAS REPLACED DUE TO INSTABILITY. THE RESULT OF INSTABILITY IS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DATE OF IMPLANT WAS (B)(6) 2023.

  Patient problems: Joint Laxity

  MAUDE report 20637055 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED STEM/HEADBALL AND LINER DUE TO INSTABILITY AND RESULT OF INSTABILITY IS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20632612 ↗
• InjuryJul 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FIRST REVISION ON (B)(6) 2024 WITH CHANGE TO A DYSPLASIA INLAY AND A MERETE CERAMIC HEAD 32 MM WITH HEAD CONE ADAPTER 2 XL 7.5 DEGREES.

  Patient problems: Joint Dislocation

  MAUDE report 19825403 ↗
• InjuryDec 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CHRONIC DISLOCATIONS. CONVERTED TO CONSTRAINED LINER. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2017. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13014028 ↗
• InjuryJun 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10130539 ↗
• InjuryNov 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9290117 ↗
• InjuryJun 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY RIGHT THR ON (B)(6) 2012. PATIENT DID WELL UNTIL A COUPLE OF YEARS AGO, WHEN SHE FELL AND DISLOCATED. THE SURGEON RELOCATED HER RIGHT HIP BUT FELL AGAIN RECENTLY, DISLOCATING THE RIGHT HIP AGAIN. THE STEM AND CUP ARE WELL FIXED. THE CUP ORIENTATION AND INCLINATION IS GOOD. THE SURGEON DETERMINED THE BEST OPTION WAS RE-OPERATION USING A CONSTRAINED LINER. HE DID SO ON (B)(6) 2019. DOI: (B)(6) 2012; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8664986 ↗
• InjuryApr 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PFS ALLEGES PAIN, MOVEMENT DIFFICULTY AND IMPAIRED SEXUAL ACTIVITY.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 8518318 ↗
• InjuryFeb 6, 2019Naturally Worn; Naturally Worn

  PINNACLE POLY ON CERAMIC LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC METAL IONS AND PARTICLES RELEASE INTO BLOOD, TISSUE AND BONE.

  Patient problems: No Code Available

  MAUDE report 8310829 ↗
• InjuryAug 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES COMPONENT FRACTURE, DISLOCATION WITH CLOSED REDUCTION AND INFECTION. THERE IS NO REVISION REPORTED AT THIS TIME. DOI: (B)(6) 2011; DOR: NOT REPORTED; RIGHT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 7738652 ↗
• InjuryAug 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS DISLOCATION OF LEFT TOTAL HIP REPLACEMENT. OPERATIVE FINDINGS STATES THAT DISLOCATION OCCURRED WITH EXTREME FLEXION AND INTERNAL ROTATION. REVISION NOTES REPORTED THAT IT WAS VERY DIFFICULT TO REDUCE THE HIP, THERE WAS A DEFORMITY OF THE SOCKET RIM, A LARGE AMOUNT OF BLOOD STAINED FLUID WHICH EMITTED FROM THE JOINT AND THERE WERE NO SIGNS OF INFECTION. DOI: (B)(4) 2015; DOR: (B)(6) 2015; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7738618 ↗
• InjuryDec 7, 2017Disassembly; Fracture; Disassembly; Fracture

  DER STATES THAT THE LINER WAS BROKEN AND THE HEAD HAD WORN TO THE METAL CUP. LINER WAS ALSO LOOSE FROM THE CUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7095691 ↗
• InjuryNov 2, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6998092 ↗
• InjuryOct 23, 2017Disassembly; Noise, Audible; Disassembly; Noise, Audible

  IT STATES THAT THE PINNACLE HIP ACETABULAR COMPONENT REVISED DUE TO POLY LINER DISASSOCIATION. ALSO, OPERATED HIP WORKED FINE UNTIL (B)(6) 2017, WHEN UNEXPECTEDLY IT BEGAN TO SQUEAK LOUDLY AS A DRY DOOR HINGE. THE VOICE WAS CLEARLY AUDIBLE TO OUTSIDERS TOO. THE NEXT DAY, THE HIP STARTED TO BOTHER AND LOCKED UP SO THAT THE KNEE COULD NOT BE RAISED TO 90 DEGREES. ORTHOPEDIC SURGEON TOLD DURING THE SURGERY THAT THE ARTIFICIAL HIP WAS IMPLANTED CORRECTLY. HE COULD NOT EVEN SAY WHY IT WAS BROKEN. OVERWEIGHT SHOULD NOT BE A CAUSE FOR BREAK BECAUSE MY SISTER HAS THE SAME ARTIFICIAL JOINTS IN BOTH HIPS AND IS CONSIDERABLY MORE OVERWEIGHT THAN ME. SHE HAS HAD NO PROBLEMS AND THEY HAVE BEEN SEVERAL YEARS, ANOTHER SIX YEARS AND THE OTHER FOUR.

  Patient problems: No Information

  MAUDE report 6968585 ↗
• InjuryAug 18, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION AND INSTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 6803925 ↗