PINNACLE 1219-28-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295013617), received between Oct 26, 2017 and Oct 18, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY OM (B)(6) 2024, DUE TO BREAKAGE/LOOSENING OF THE MARATHON +4 10 POLYETHYLENE INSERT IN THE SMALL PINNACLE CUP SIZE (44 TO 50) WITH 28 OR 32MM HEADS (RIGHT SIDE).

  Patient problems: Insufficient Information

  MAUDE report 20480500 ↗
• InjuryMar 8, 2024Fracture; Fracture

  AFTER THE FIRST HIP SURGERY, THE PATIENT WAS QUALIFIED FOR A REVIEW OPERATION. BROKEN INSERT.

  Patient problems: Insufficient Information

  MAUDE report 18864272 ↗
• InjuryNov 20, 2023Naturally Worn; Naturally Worn

  PATIENT REQUIRED A HEAD LINER EXCHANGE FROM A RIGHT THR DUE TO POLY LINER WEAR. LINER WAS A PINNACLE LIPPED LINER IN SIZE 50, AND A CERAMIC HEAD 28 +5.

  Patient problems: Insufficient Information

  MAUDE report 18168922 ↗
• InjuryJul 26, 2023Naturally Worn; Naturally Worn

  OPERATIVE NOTES REVIEWED. ON (B)(6) 2023, THE PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS PAIN, SUBLUXATION/INSTABILITY, AND RADIOGRAPHIC EVIDENCE OF POLYETHYLENE LINER WEAR. THE FEMORAL STEM AND ACETABULAR CUP WERE FOUND TO BE INTACT, UNDAMAGED, AND WELL-FIXED--BOTH WERE RETAINED. THE LINER WAS FOUND TO BE WORN. THE HEAD AND LINER WERE REVISED. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 17395955 ↗
• InjuryMay 9, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  DATE EVENT (=DATE THE ISSUE TOOK PLACE): (B)(6) 2023. ( REVISION ) IMPLANTATION: (B)(6) 2019. PROCEDURE: TOTAL HIP AFTER A FRACTURE. DESCRIPTION OF ISSUE: LUXATION OF LINER, SCALLOPS OF THE LINER HAVE BROKEN OFF. WHEN DID THE EVEN OCCUR (PRE-OP/INTRA-OP/POST-OP)? POST-OP. WAS THERE ANY PATIENT CONSEQUENCE? YES , REVISION SURGERY ON DATE: (B)(6) 2023. WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? REVISION SURGERY, PLACED A NEW LINER. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE (MINUTES)?

  Patient problems: Insufficient Information

  MAUDE report 16896562 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16293838 ↗
• InjuryFeb 2, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PATIENT REQUIRED REVISION SURGERY FOR A LINER AND HEAD EXCHANGE DUE TO THE PATIENT DISLOCATING. PATIENT DIDN'T HAVE ANY SORT OF FALL OR TRAUMA. SHE HAD A SPONTANEOUS DISLOCATION. ORIGINAL PRIMARY SURGERY DONE BY DR (B)(6) AT (B)(6) ON THE (B)(6) 2010 AND THE LEFT SIDE WAS OPERATED ON. WHEN THE POLY WAS REMOVED, WEAR COULD BE SEEN ON THE EDGE OF LINER, WHICH INDICATES THE HEAD MAY HAVE BEEN PISTONING IN AND OUT OF THE CUP FOR SOMETIME, WITHOUT THE PATIENT REALIZING. DOI: (B)(6) 2010; DOR: (B)(6) 2022 LEFT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 13423112 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REFERRED TO FRED PHILLIPS DUE TO PATIENT COMPLAINING OF INSTABILITY, HAD PREVIOUS DISLOCATION OF HIP JOINT REPLACEMENT, HOWEVER UNABLE TO GAIN THE DATE. PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2017 AT ANOTHER HOSPITAL. PROCEDURE BOOKED ON THIS DAY IS TO REVISE THE PINNACLE POLYETHYLENE LINER AND HEAD AND REPLACE WITH PINNACLE DUAL MOBILITY CONSTRUCT. IF OTHER, DESCRIBE : UNABLE TO STATE WHEN DISLOCATION OCCURED, IF OTHER, DESCRIBE : HIP ARTHROPLASTY, PATIENT STATUS/ OUTCOME / CONSEQUENCES : YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PREVIOUS DISLOCATION, AND SUBSEQUENT INSTABILITY,

  Patient problems: Joint Laxity

  MAUDE report 12969156 ↗
• InjuryFeb 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CHRONIC DISLOCATION OF THR. LINER REPLACED FOR CONSTRAINED LINER. STEM/CUP REMAINED INSITU. CORAIL PINNACLE THR (B)(6) 2017.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11378610 ↗
• InjuryApr 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING POSTERIORLY. FEMORAL HEAD AND ACETABULAR LINER WERE EXCHANGED AT REVISION. IT WAS ALSO INDICATED THAT THE PATIENT PRACTICED YOGA PRIOR TO DISLOCATION. SHE SUFFERED FROM RECURRENT DISLOCATIONS. DOI: 2011; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8491170 ↗
• InjuryMar 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AND ELEVATED METAL IONS AFTER 1ST REVISION. DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8429040 ↗
• InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION WITH CLOSED REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 8176773 ↗
• InjuryMay 11, 2018Naturally Worn; Naturally Worn

  DER STATES PATIENT WAS REVISED DUE TO WORE THROUGH POLYETHLENE. DOI: UNKNOWN DOR: (B)(6) 2018, LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7508105 ↗
• InjuryFeb 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR UNKNOWN REASON. DOI: UNKNOWN; DOR: (B)(6) 2017. THE ACETABULAR CUP WAS REVISED AS THE PATIENT KEPT DISLOCATING AND THEREFORE WAS UNABLE TO BE DISCHARGED POST PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 7281966 ↗
• InjuryNov 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT DESCRIPTION: DER STATES THAT THE PATIENT HAS BEEN DISLOCATING ON MULTIPLE OCCASIONS. IT WAS REPORTED THAT THE SURGEON ELECTED TO EXCHANGE THE ACETABULAR LINER AND FEMORAL HEAD TO GAIN MORE OVERALL HIP STABILITY. / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: Joint Dislocation

  MAUDE report 7011981 ↗
• InjuryOct 26, 2017Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLYETHYLENE WEAR.

  Patient problems: No Information

  MAUDE report 6982398 ↗