PINNACLE 1219-28-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295013303), received between Aug 11, 2017 and Apr 25, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: POLY DISASSOCATION AND PAIN. AT REVISION FRETTING WAS NOTED ON THE FEMORAL HEAD. MODERATE YELLOWING AND NECK IMPINGEMENT WAS NOTED WITH THE ACETABULAR LINER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19183616 ↗
• InjuryAug 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S POLY DISASSOCIATED FROM CUP. THIS IS THE SECOND TIME THIS PATIENT HAS UNDERGONE REVISION SURGERY FOR THIS SAME PROBLEM. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17490628 ↗
• InjuryMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2005; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13938008 ↗
• InjuryNov 10, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE PATIENT WAS REVISED DUE TO DISLOCATED HIP AND POLY WEAR. DOI: 2004, DOR: OCT 26, 2020, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10815912 ↗
• InjuryOct 25, 2019Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  THE DR. DESCRIBED THAT THE PINNACLE POLY ¿DISENGAGED¿ FROM THE PINNACLE CUP DUE TO LOCKING MECHANISM ISSUE. HE STATED THAT THERE IS AN ISSUE WITH OUR LOCKING MECHANISM AND THIS IS THE 5TH DISASSOCIATION HE HAS SEEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: 0. 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: No Code Available

  MAUDE report 9240627 ↗
• InjuryApr 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON DID A LINER EXCHANGE DUE TO THE LINER DISENGAGED FROM THE CUP. SURGEON STATED PATIENT TRIPPED AND FELT SOMETHING IN HER HIP. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8551674 ↗
• InjuryDec 7, 2018Unstable; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Unstable; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO INSTABILITY AND FREQUENT DISLOCATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 8143833 ↗
• InjuryNov 7, 2018Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  REVISION RELATED TO PAIN.

  Patient problems: Pain

  MAUDE report 8045828 ↗
• InjuryJul 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  EVENT OR PRODUCT PROBLEM OUTCOME LUXATION OF A PINNACLE LINER OUT OF THE PINNACLE SHELL. THE PATIENT HAD BENDED FORWARD, FELT SOMETHING GLIDING AND HEARD A KIND OF CRACK. THIS HAD HAPPENED BEFORE ONLY THIS TIME THERE WAS A LOT OF PAIN AND THE FEELING THAT SOMETHING WAS TERRIBLY WRONG. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME REVISION SURGERY WAS NECESSARY, SURGEON REPLACED THE PINNACLE SYSTEM BY A SYSTEM OF THE DESCRIBE EVENT PATIENT FELL FROM HER BICYCLE ON HER RIGHT HIP AND FELT PAIN IN HER LEFT HIP OMPETITOR. PATIENT INFORMATION: (B)(6). DATE THE EVENT, IF DIFFERENT FROM DATE OF PROCEDURE/SURGERY: PRIMARY SURGERY: (B)(6) 2010 REVISION SURGERY: (B)(6) 2018.

  Patient problems: Pain

  MAUDE report 7726340 ↗
• InjuryJul 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF TOTAL FEMUR. THE PATIENT ALSO HAD A TOTAL KNEE AND A TOTAL HIP WHICH FRACTURED AND WAS REVISED WITH LONG STEM PROSTHESIS YEARS AGO. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 7718111 ↗
• InjuryJul 25, 2018Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  DIRECT CONTACT BETWEEN THE HEAD AND THE ACETABULUM (PINNACLE). THAT LED TO CHANGE IN THE SHAPE OF THE POLYETHYLENE INSERT AND BREAKAGE OF 4 SPINES. ACTION TAKEN WAS THE HEAD AND THE INSERT WAS CHANGED. PRIMARY SURGERY DATE WAS ON (B)(6) 2017.

  Patient problems: Joint Disorder; Limited Mobility Of The Implanted Joint

  MAUDE report 7717675 ↗
• InjuryMay 18, 2018Disassembly; Disassembly

  DER STATES DISASSOCIATION OF LINER. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2002; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Injury; Not Applicable

  MAUDE report 7525714 ↗
• InjuryAug 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 6787758 ↗