PINNACLE 1219-36-456Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295014720), received between Jul 27, 2017 and Jun 11, 2025 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A REMOVAL OF LINER AND INSERTION OF CONSTRAINED LINER (DISLOCATION). THE COMPETITOR HEAD AND STEM WERE KEPT IN PLACE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22187154 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (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 DUE TO INFECTION AND PAIN. AT REVISION THERE WAS CORROSION IN THE BORE OF THE FEMORAL HEAD.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21026539 ↗
• MalfunctionMar 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR INITIAL DISLOCATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (RIGHT HIP). TREATMENT: KNEE IMMOBILIZER.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 16477145 ↗
• InjuryJan 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS DISLOCATED HIP, THE SURGEON PUT IN A CONSTRAINED LINER. IT WAS UNKNOWN IF ANY LOOSENING REPORTED. IT WAS UNKNOWN IF ANY SURGICAL DELAY REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16120810 ↗
• InjuryMar 23, 2022Noise, Audible; Noise, Audible

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF HIP TO ADDRESS PERIPROSTHETIC FEMUR FRACTURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF REVISION: (B)(6) 2022; (LEFT HIP). TREATMENT: REVISION OF FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER.

  Patient problems: Hematoma; Nerve Damage; Pain; Physical Asymmetry; Unspecified Tissue Injury

  MAUDE report 13860361 ↗
• InjuryJan 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION, SO WE REPLACED LINER TO A CONSTRAINED LINER. DOI: (B)(6) 2012; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9629263 ↗
• InjuryNov 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEFT HIP DISLOCATION. REVISION DATE (B)(6) 2019.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9363777 ↗
• InjuryJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON JULY 30, 2019. THE PATIENT WAS SUPPOSED TO BE REVISED ON (B)(6) 2019, HOWEVER IT WAS UNSUCCESSFUL DUE TO DIFFICULTY IN REMOVING THE IMPLANTS AND BROKEN INSTRUMENTATION. PATIENT THEN HAD A SUCCESSFUL REVISION ON (B)(6) 2019 AND REPLACED WITH PROSTALAC PROSTHESIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8812929 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT SUPERFICIAL HEMATOMA. THE PATIENT HAD PREVIOUSLY UNDERGONE 5 TO 6 ASPIRATIONS TO TREAT THE HEMATOMA. OPERATIVE FINDINGS INCLUDE A LARGE HEMATOMA AND A RENT IN THE DEEP TISSUE ANTERIOR TO THE TROCHANTER AND EXTENDING INTO THE DEEP AREA OF THE HIP. DOI: (B)(6) 2010 - DOR: NO REVISION - DOE: (B)(6) 2011 (LEFT HIP).

  Patient problems: Hematoma; No Code Available

  MAUDE report 8716727 ↗
• InjuryMar 18, 2019Insufficient Device Problem Information

  IT WAS REPORTED THAT AS PER SURGEON, PATIENT WAS BEING REVISED FOR PAINFUL HIP. SWAPPED LINER AND INCREASED BALL LENGTH WITH REVISION HEAD. DOI: (B)(6) 2013. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8429099 ↗
• InjuryFeb 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEET RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2012 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8353270 ↗
• InjuryFeb 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES, DISLOCATION WITH CLOSED REDUCTION AND ELEVATED METAL IONS. STEM WERE ALREADY REPORTED IN THE FIRST REVISION. DOI: (B)(6) 2015; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8338961 ↗
• InjuryFeb 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES, DISLOCATION WITH CLOSED REDUCTION AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2015 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8336003 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO PAIN AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8217213 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8047937 ↗
• InjuryJun 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS ANTERIOR DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7605267 ↗
• InjuryDec 22, 2017Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES MULTIPLE DISLOCATION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RIGHT HIP STATUS POST TOTAL HIP ARTHROPLASTY WITH RECURRENT DISLOCATION. REVISION NOTE REPORTED THE MUSCULATURE AROUND THE HIP APPEARED TO BE BASICALLY BROWN AND NECROTIC, BUT NOT INFECTED OR GANGRENOUS, DISLOCATED MULTIPLE TIMES, ABDUCTOR MECHANISM OF THE GREATER TROCHANTER HAS BEEN AVULSED, THE BONE WAS STRIPPED ALL THE WAY DOWN AROUND THE LESSER TROCHANTER, CONSISTED WITH COMPLETE AVULSION OF THE ILIOPSOAS AND ALL SOFT TISSUE HAD ERODED OFF. IT WAS ALSO MENTION THAT THERE WAS NO EVIDENCE OF INFECTION, METALLOSIS, ANY PURULENCE OR GROSS LOOSENING OF THE COMPONENTS AND NO SIGNS OF ANY GANGRENOUS OR GAS TYPE TISSUES.

  Patient problems: Deformity/ Disfigurement; Distress; Host-Tissue Reaction; Injury; Joint Dislocation; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Pain

  MAUDE report 7141774 ↗
• InjuryNov 4, 2017Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE 36 CERAMIC HEAD BROKE. UPDATE OCT 5, 2017: LITIGATION RECORD RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES PAIN, DISCOMFORT AND FAILURE OF ACETABULAR LINER. ADDED COMPLAINANT INFORMATION. ADDED UNKNOWN LINER. THIS COMPLAINT WAS UPDATED ON OCT 13, 2017. UPDATE OCT 21, 2017: PFS AND MEDICAL RECORD RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED FOR MDR REPORTABILITY, MEDICAL RECORDS REPORTED THAT PATIENT HAD AN UNUSUAL SENSATION, POPPING IN THE HIP, AND UNABLE TO BEAR HIS WEIGHT. REVISION NOTES REPORTED THAT THE SURGEON FOUND BROKEN BITS OF CERAMIC, BROKEN CERAMIC HEAD, DISLOCATED HIP, SCRATCHES ON THE TRUNNION, AND WEARING OF THE HEAD AND LINER. THIS COMPLAINT WAS UPDATED ON OCT 27, 2017.

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

  MAUDE report 7002159 ↗
• InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6746560 ↗