PINNACLE 1219-28-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295013464), received between Dec 22, 2017 and Sep 8, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  SURGEON REPORTED TO BF ARM: "ON 08-AUG THE PATIENT HAD SUDDEN GROIN PAIN ON THE RIGHT SIDE, SINCE 10-AUG THERE IS A SQUEAKING NOISE IN THE AREA OF THE RIGHT HIP JOINT. THE PATIENT PRESENTED HERSELF YESTERDAY IN THE DOCTOR'S OFFICE; THE INDICATION FOR A HIP TEP REPLACEMENT BECAUSE A DECENTERED HEAD IN THE CUP WAS GIVEN. (B)(6) 2017 IMPLANTATION OF A CEMENTLESS TOTAL ENDOPROSTHESIS RIGHT HIP (CORAIL STEM SIZE 10, HEAD SIZE 28/+5, PINNACLE CUP SIZE 50/28 MM). (B)(6) 2022. EXPLANTATION OF THE BROKEN INLAY. THE INLAY WAS ALSO LUXATED." DOI: (B)(6) 2017. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Pain; Physical Asymmetry; Scar Tissue

  MAUDE report 15378765 ↗
• InjuryDec 6, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE RIGHT HIP REVISED FOR PAIN AND POLY WEAR. THA WAS DONE IN ABOUT 2005. NO ADDITIONAL INFORMATION OR RECORDS AVAILABLE. DOI: (B)(6) 2005; DOR: (B)(6) 2021; (RIGHT HIP).

  Patient problems: Pain

  MAUDE report 12934207 ↗
• InjuryJun 7, 2021Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  1. EVENT DESCRIPTION STATED, "PATIENT UNDERWENT PRIMARY BILATERAL TOTAL HIP REPLACEMENT". WAS THE REVISION SURGERY BILATERAL AS WELL? THE ORIGINAL SURGERY WAS A BILATERAL. THIS REVISION SURGERY IS FOR THE RIGHT HIP ONLY ¿ THE LEFT HAS NOT REQUIRED A REVISION. IF YES; PLEASE PROVIDE THE DATE OF REVISION AND THE PRODUCT DETAILS OF THE EXPLANTED DEPUY IMPLANTS OF EACH SIDE. NA. IF NO; PLEASE ADVISE WHICH WAS THE AFFECTED SIDE. RIGHT. 2. DO YOU BELIEVE THERE WAS ANY IMPINGEMENT BEFORE THE DISASSOCIATION EVENT? OR WAS IT A RESULT OF THE LINER COMING OUT OF THE CUP? HARD TO TELL, BUT THE FEELING FROM THE SURGEON IS THAT PERHAPS THE ORIGINAL LINER WAS NOT ENGAGED ¿ AT TIME OF OPENING THE HIP THE LINER WAS FREE FLOATING AND WHEN THE SURGEON TRIED TO IMPACT THE NEW LINER, IT ACTUALLY SLIPPED AND DID NOT ENGAGE (DUE TO SURGICAL TECH/ EXPOSURE) AND ANOTHER LINER WAS USED. THIS LET TO THE THOUGHT THAT PERHAPS THE ORIGINAL IMPLANTING SURGEON MAY HAVE DONE THE SAME POLY LINER BREAKDOWN WITH ASYMMETRIC WEAR

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

  MAUDE report 11953318 ↗
• InjuryDec 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISLOCATIONS IN RIGHT HIP POSSIBLY DUE IN PART BECAUSE OF WEIGHT LOSS COMBINED WITH AGING. THE SURGEON INITIALLY PLANNED TO INCREASE THE NECK LENGTH OF THE HEAD BALL, BUT DUE TO HER SOFT TISSUE LAXITY AND WITH THE ACETABULAR CUP BEING IN A SOMEWHAT VERTICAL POSITION, DECIDED TO REPLACE THE ACETABULAR COMPONENT. IMPLANT REMAINING IN PATIENT: 1554-01-121 DW2A51000 AML SMALL STATURE STEM 12.0MM. DOI: (B)(6) 2009. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9415794 ↗
• InjuryMay 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEET RECEIVED. PPF ALLEGES DISLOCATION. DOI: (B)(6) 2002, DOR: (B)(6) 2014 (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8631798 ↗
• InjuryDec 11, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  REVISION DUE TO SPLIT LINING AND DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8150486 ↗
• InjurySep 17, 2018Naturally Worn; Separation Problem; Naturally Worn; Separation Problem

  CUSTOMER REPORTED TO (B)(6): "PRIMARY IMPLANTATION OF A CEMENTLESS DEPUY HIP-TEP (PINNACLE CUP / CORAIL STEM) RIGHT ON (B)(6) 2015. INITIALLY INCONSPICUOUS POST-OP COURSE. PATIENT INDICATED OCCURRENCE OF NOISE PHENOMENA IN THE AREA OF THE HIP TEP ON THE RIGHT SIDE SINCE ABOUT (B)(6) 2016. A PREVIOUS RELEVANT TRAUMA / MOVEMENT MOMENT IS NEGATED BY THE PATIENT. IN THE FURTHER COURSE PERSISTENCE OF NOICE PHENOMENA AND ADDITIONALLY PAIN SINCE (B)(6) 2018. THEREUPON VISIT AT THE ORTHOPEDIC PRACTITIONER ON (B)(6) 2018 AND X-RAY EXAMINATION OF RIGHT HIP-TEP. ON THE SAME DAY VISIT AT OUR HOSPITAL´S ORTHOPEDIC EMERGENCY ROOM. RADIOGRAPH SHOWED DECENTRALISATION OF HIP HEAD OF THE HIP PROSTHESIS WITHOUT EVIDENCE OF LUXATION. ON (B)(6) 2018 REVISION OF HIP-TEP RIGHT SIDE. INTRAOPERATIVELY A SEVERE METALLOSIS AND A DISLOCATION OF THE INLAY FROM THE PINNACLE-PRESSFIT CUP WAS OBVIOUS - AN EXPLANATORY CORRELATE FOR THIS WAS NOT EVIDENT. IN ADDITION THERE WAS WEAR/DAMAGE OF PINNACLE CUP CAUSED BY THE CERAMIC HEAD. A RADICAL DEBRIDEMENT WAS DONE AS WELL AS A REVISION OF HIP-HEAD AND CUP."

  Patient problems: Not Applicable; Pain; Tissue Damage

  MAUDE report 7881537 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PFF AND STICKER SHEETS RECEIVED. PFF ALLEGES ELEVATED METAL ION. THERE WERE NO LABORATORY RESULT TO SUPPORT ELEVATED METAL IONS. DURING THE REVISION, THE IMPLANTS THAT WAS REMOVED WAS NOT SPECIFIED. DOI: (B)(6) 2010 FOR HEAD AND LINER. DOI: (B)(6) 2009 FOR STEM. DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: No Code Available; Not Applicable; Test Result

  MAUDE report 7618632 ↗
• InjuryDec 22, 2017Disassembly; Material Separation; Noise, Audible; Disassembly; Material Separation; Noise, Audible

  THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF HIP-HEAD AND INLAY.

  Patient problems: Joint Disorder; No Consequences Or Impact To Patient; No Information

  MAUDE report 7142711 ↗