PINNACLE 1219-36-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295014478), received between Nov 10, 2017 and Sep 11, 2026 — classified as 20 injuries, 3 malfunctions.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Device Dislodged or Dislocated

  It was reported the patient had a Corail Stem, a pinnacle cup and a marathon liner. After 8 years, the liner unclipped and slipped so patient had to be revised for a new liner and head for his hip replacement. Revision surgery went well.DOI: 8 years ago .DOE: (b)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 50737288 ↗
• InjurySep 10, 2026Device Dislodged or Dislocated; Naturally Worn

  It was reported that the patient presented acutely at ED on (b)(6) 2026 unable to weight-bear on right side 10 years post THA following a deep flexion movement (no fall). The patient was taken to theatre on (b)(6) 2026 and revision of liner and head was performed. A 56 x 36 lipped ALTRX liner was implanted and a 1.5mm Delta TS head. The surgeon was confident there was no damage to inner surface of cup insitu and decided to leave in place.

  Patient problems: Loss of Range of Motion

  MAUDE report 50713297 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER REVISED FOR PROGRESSIVE OSTEOLYSIS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Osteolysis

  MAUDE report 24926211 ↗
• InjuryDec 9, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT HIP WAS REPLACED 15 YRS AGO AT A DIFFERENT HOSPITAL; THE EXACT DATE IS NOT KNOWN. X-RAYS SHOW THE LEFT HIP PARTIALLY SUBLUXED SUPERIOR AND LATERALLY. IT WAS DISCOVERED AFTER DISLOCATION THAT THE POLY LINER HAD ROTATED IN THE CUP TO A POSITION THAT ALLOWED THE FEMORAL HEAD TO ARTICULATED AGAINST THE INSIDE SUPERIOR PORTION OF THE ACETABULAR CUP GENERATING A FAIR AMOUNT OF TITANIUM WEAR DEBRIS. THE DEBRIS WAS IRRIGATED FROM THE HIP AREA. FOUR OF THE SIX ARD'S ON THE POLY LINER HAD BEEN SHEARED OFF. THERE WAS LOOSENING OF ACETABULAR LINER AT BONE TO IMPLANT INTERFACE. THE CONDITION OF THE CUP WAS ASSESSED AND FOUND TO BE ADEQUATE FOR CONTINUED USE. AN ALTRX LINER, 36MM X 58MM +4 10° WAS IMPACTED IN THE CUP AND A NEW FEMORAL HEAD WAS IMPACTED ON THE AML TRUNION. NO OTHER IMPLANTS WERE REMOVED/REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 23757489 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS IS THE SECOND REVISION OF THIS ACETABULUM, THE FIRST PROCEDURE WAS REPORTED WITH (B)(4). THE POLYETHYLENE LINER BECAME DISSOCIATED FROM THE PINNACLE SECTOR CUP IN THAT INSTANCE, AND THE SAME HAS HAPPENED HERE.

  Patient problems: Insufficient Information

  MAUDE report 19742684 ↗
• InjuryJul 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A NEW LINER REVISION DUE TO DISLOCATION IN THE PATIENT. UNABLE TO TELL ONCE IN SURGERY AS NO SOFT TISSUE IMPINGEMENT WAS DETECTED. LINER WAS THROWN AWAY. DOI: (B)(6) 2024. DOE: (B)(6) 2024.

  Patient problems: Joint Dislocation

  MAUDE report 19730845 ↗
• MalfunctionApr 15, 2024Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PINNACLE NEUTRAL LINER APPEARS TO HAVE HAD THE INNER PACKAGING CORNER SEALED WITHIN THE OUTER PACKAGING. THIS MEANT THAT WHEN THE PACKET WAS OPENED THE SECOND LAYER WAS ALSO PARTIALLY TORN AT THE SAME TIME. THE STAFF WERE STILL HAPPY TO USE THE LINER AS THEY DETERMINED IT WAS STILL STERILE SO THERE WAS NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103970 ↗
• InjuryDec 11, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S HIP WAS UNSTABLE. IT WAS A PINNACLE CUP. LINER AND HEAD WERE REMOVED AND REPLACING WITH NEW LINER AND HEAD. IN SURGERY IT WAS DISCOVERED THAT SHE EXHIBITS "TRUNIONOSIS" AND "ECCENTRIC POLY WEAR". A DUAL MOBILITY LINER AND A +1.5 X 28MM HEAD WERE IMPLANTED. SURGICAL DELAY UNKNOWN. (B)(6). AFFECTED SIDE: RIGHT HIP

  Patient problems: Foreign Body Reaction; Joint Laxity

  MAUDE report 18302358 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT CORAIL/PINNACLE TOTAL HIP REPLACEMENT THREE YEARS AGO. PRESENTED BACK TO GP WITH COMPLAINT OF PAIN. X-RAY TAKEN WHICH SHOWED AN AREA OF SINUS TRACKING IN THE BONE SUSPICIOUS OF INFECTION. PROCEDURE REMOVAL OF CORAIL/PINNACLE HIP REPLACEMENT, RIGHT AND INSERTION OF 'KIWI SPACER', IE LOOSELY CEMENTED C-STEM AND MARATHON CEMENTED CUP. UPON REMOVING THE CORAIL STEM THE SURGEON STATED HE COULD SEE 'AN AREA OF PUS' IN THE FEMORAL CANAL. DOI: UNKNOWN, DOR: (B)(6) 2023, RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16252764 ↗
• InjuryFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE LINER DISASSOCIATING FROM THE CUP. THE LINER WAS REMOVED AND REPLACED WITH A DUAL MOBILITY LINER AND DUAL MOBILITY HEAD. DOI: 2010; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 13480949 ↗
• InjuryAug 16, 2021Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: DOI: APPX 8 YEARS AGO, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 12324978 ↗
• InjurySep 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE MARATHON LINER DISASSOCIATED FROM ACETABULAR CUP. HEAD AND LINER EXCHANGE WERE PERFORMED.

  Patient problems: No Code Available

  MAUDE report 10600952 ↗
• InjuryJun 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED LEFT HIP. SURGEON REMOVED HEAD AND LINER. REPLACED LINER WITH A CONSTRAINED LINER AND PLACED A NEW METAL HEAD AS WELL. THE G2 STEM AND PINNACLE CUP REMAINED IMPLANTED. DOI: (B)(6) 2004. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10178399 ↗
• MalfunctionFeb 21, 2020Component Missing; Component Missing

  CIRCULATING NURSE OPENED STERILE IMPLANT BOX FOR THE SCRUB NURSE AND THE TOP PART WAS PROPERLY STERILE SEALED, BUT THE BOX INSIDE WHERE THE IMPLANT WAS, WAS WITHOUT SEAL AT ALL. NORMALLY THERE SHOULD BE ANOTHER STERILE, SEALED BOX. THEY PUT THAT LINER IMPLANT FOR THE PATIENT.

  Patient problems: No Code Available; No Patient Involvement

  MAUDE report 9741868 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF HIP DUE TO INFECTION. LINER AND HEAD WAS REMOVED. SOFT TISSUE WAS DEBRIDED AND CLEANED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9490887 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THE PATIENT HAD PAIN (DEPENDENT ON STRAIN AND MOVEMENT) IN THE LEFT HIP AFTER HEARD CRACKING WITHOUT PREVIOUS TRAUMA. DUE TO THE PAIN, THE PATIENT FELL WHILE WALKING ON (B)(6) 2019. UNKNOWN PPF HIP STEM IMPLANTATION IN 1995." DOI: 1995; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9427042 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES THE PATIENT CONTINUES TO SUFFER DUE TO PAIN, ONGOING STRUGGLE WITH DEPRESSION AND PANIC DISORDER. DOI: (B)(6) 2011; DOR: NONE REPORTED (LEFT HIP). PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: No Code Available; Pain

  MAUDE report 9375482 ↗
• MalfunctionNov 15, 2019Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED FOR MEDICAL RECORDS AND IT WAS NOTED THAT ON (B)(6)2013: PATIENT UNDERWENT A LEFT HIP REPLACEMENT. NO COMPLICATIONS NOTED. (B)(6) 2019: OFFICE NOTE INDICATED THE PATIENT IS SATISFIED WITH HIS LEFT HIP REPLACEMENT. IMAGES INDICATED ALL COMPONENTS ARE IN GOOD POSITION WITH NO LOOSENING. MILD POLY WEAR WAS NOTED OF 2MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9329901 ↗
• InjuryJun 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT EXPERIENCED PAIN BEFORE THE REVISION. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. REVISION NOTES REPORTED THAT THE HEAD DID START TO LIFT NOT OF THE SOCKET , BUT DID NOT FULLY JUMP OUT AND DISLOCATE .LINER, HEAD, AND CUP WERE REMOVED BUT HEAD IS NOT A DEPUY PRODUCT. DOI: (B)(6) 2011; DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 8700352 ↗
• InjuryMay 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AFTER THE FIRST REVISION. DOI: (B)(6) 2013 - DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8635641 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION.

  Patient problems: Pulmonary Embolism

  MAUDE report 8375308 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND PAIN. DOI: UNKNOWN DOR: (B)(6) 2018 RIGHT HIP.

  Patient problems: Not Applicable; Pain; Unspecified Infection

  MAUDE report 7475989 ↗
• InjuryNov 10, 2017Disassembly; Fracture; Disassembly; Fracture

  DER STATES FAILED LINER AND ARDS HAD BEEN SHEERED OFF.

  Patient problems: No Information

  MAUDE report 7016974 ↗