PINNACLE 1219-36-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295014591), received between Jul 19, 2017 and Aug 4, 2025 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2013: SUBJECT REPORTED EVENT TO CLINICAL SITE FOR RIGHT HIP PAIN. PATIENT WAS TREATED BY STEROID INJECTION IN THE RIGHT HIP AND THIS EVENT REMAINS CONTINUING.

  Patient problems: Pain

  MAUDE report 22708645 ↗
• MalfunctionFeb 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT SCREW CROSS THREADED AND LINER CHIPPED DURING REMOVAL. DOE: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651608 ↗
• InjuryMay 3, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO PAIN , RELATED TO POLY LINER WEAR FROM PREVIOUS SURGERY IN 2006. DOI: (B)(6) 2006, DOR: (B)(6) 2023, AFFECTED SIDE : LEFT HIP.

  Patient problems: Pain

  MAUDE report 16859804 ↗
• InjurySep 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WITHIN MEDICAL DOCUMENTATION OF (B)(4) IT BECAME OBVIOUS THAT PATIENT WAS REVISED BEFORE: REVISION OF HIP HEAD AND PE INLAY LEFT HIP BECAUSE OF DISLOCATION. DOI: (B)(6) 2014; DOR: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 15462008 ↗
• InjuryMar 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO REPEATED DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 13664718 ↗
• InjuryFeb 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF THR ¿ RIGHT SIDE, PATIENT HAS BILATERAL HIP REPLACEMENTS AND A HISTORY OF CHRONIC REPEATED DISLOCATION. DOI: (B)(6) 2013. DOR: (B)(6) 2017. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13590929 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THA ON (B)(6) 2012 WHERE A SUMMIT STEM AND PINNACLE SHELL WERE UTILIZED. PATIENT COMPLAINED OF PROGRESSIVELY WORSENING GROIN PAIN AROUND THE ACETABULUM. DECISION WAS MADE TO REVISE THE ACETABULAR COMPONENT AS CT SCAN APPEAR TO INDICATE THAT THERE IS OSTEOLYSIS AND GRANULOMA BEHIND THE ACETABULAR COMPONENT. THE ACETABULAR COMPONENT WAS REVISED ALONG WITH THE HEAD OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS LEFT IN SITU AS IT WAS WELL FIXED.

  Patient problems: Osteolysis; Pain

  MAUDE report 13418876 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT FOLLOWING THE IMPLANTATION SURGERY, THE PATIENT STARTED TO SUFFER SEVERE PAIN ON THE LEFT HIP (THE ONE WHICH HAD BEEN REVISED). THUS, CONSIDERED THAT THE PROSTHESIS MUST HAVE FAILED. AFFECTED SIDE WAS THE LEFT HIP.

  Patient problems: Pain

  MAUDE report 12884172 ↗
• InjuryJun 9, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HIS REPLACED 14 YEARS AGO BY ANOTHER SURGEON AT ANOTHER HOSPITAL WHICH WAS NOT KNOWN AT THE TIME I ASKED DURING SURGERY. THIS PATIENT DID WELL UNTIL RECENTLY WHERE HE CAME IN TO SEE THE SURGEON. THE X-RAYS INDICATED THE FEMORAL HEAD WAS ARTICULATING ON THE CUP. THE SURGEON AND THE PATIENT DECIDED THAT A REVISION WOULD BE DONE TO CORRECT THE ISSUE. DURING THE SURGERY THE 56MM ACETABULAR SECTOR CUP, 56MM MARATHON LINER, AND A 36MM 8.5 HIP BALL WERE EXPLANTED. THE AML STEM, LOTT AND CAT # UNKNOWN WAS LEFT IN VITRO. THE ACETABULAR LINER WAS BROKEN AND THE HIP BALL WAS RUBBING AGAINST THE ACETABULAR CUP WHICH CAUSED SIGNIFICANT DAMAGE TO THE FEMORAL HEAD AND LINER. A NEW COMPETITOR CUP WAS IMPLANTED. DOI: 14 YEARS AGO - DOR: (B)(6) 2021 (LEFT HIP).

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

  MAUDE report 11968604 ↗
• InjuryFeb 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF TOTAL HIP REPLACEMENT FOR CHRONIC DISLOCATION. REVISED TO PINNACLE CONSTRAINED LINER AND FEMORAL HEAD CHANGE. PRIMARY SURGERY BELIEVED TO BE IN 2013. NO SURGEON OR PRIMARY SITE HOSPITAL OF IMPLANTATION AVAILABLE OR COULD BE CONFIRMED. THE PATIENT NEEDED A CONSTRAINED LINER FOR RECURRENT DISLOCATION AND INSTABILITY. NO FURTHER DETAILS ARE AVAILABLE FOR THIS CASE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11372102 ↗
• InjuryJan 27, 2021Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO POLY WEAR AND MALALLIGNED OF CUP. DOI: UNKNOWN; DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Insufficient Information

  MAUDE report 11239866 ↗
• InjuryAug 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON PERFORMED A PINNACLE LINER AND HEAD EXCHANGE FOR A DISSOCIATED PINNACLE LINER. SURGEON REPORTED HE PERFORMED THE PRIMARY SURGERY APPROX 2 YEARS AGO AND THAT THE PATIENT DID NOT REPORT ANY TRAUMATIC EVENT WHICH COULD HAVE CAUSED THE LINER DISSOCIATION. HE SAID PATIENT PRESENTED TO ED ABOUT A WEEK AGO WITH HIP PAIN AND X-RAY INVESTIGATION CONFIRMED LINER DISSOCIATION. REVISION OF PINNACLE LINER AND EXCHANGE OF FEMORAL HEAD COMPLETED AS PLANNED ON (B)(6) 2020. PHOTOS OF EXPLANTED IMPLANTS AVAILABLE HOWEVER IMPLANTS NOT AVAILABLE FOR RETURN AND WILL BE RETAINED BY HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10453710 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN, LACK OF MOBILITY, SWELLING, SEVERE SORENESS, INFLAMMATION, AND DAMAGE TO SURROUNDING BONE AND TISSUE. PATIENT WAS ALREADY DEAD. DATE OF DEATH: UNKNOWN.

  Patient problems: Discomfort; Inflammation; Loss of Range of Motion; No Code Available; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10071356 ↗
• InjuryMay 6, 2020Fracture; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PROSTHETIC FRACTURE. PLAINTIFF IS SEEKING FULL COMPENSATION FOR ALL THE DAMAGES THAT HAD CAUSED HER SUCH AS PERMANENT BIOLOGICAL INJURY, IMPAIRED MOBILITY, LIMITED ADL, JOINT INSUFFICIENCY, FINANCIAL LOSSES AND SOCIAL INTERACTIONS DUE TO DEFECTIVE AND LACK OF SAFETY PRODUCTS IMPLANTED.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 10028743 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR AND ABDUCTOR MUSCLE REPAIR AFTER 1ST REVISION. DOI: (B)(6) 2004 (CUP, SCREWS); DOR: (B)(6) 2017 (HEAD, LINER); (LEFT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; Tissue Damage

  MAUDE report 9539793 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. THERE WERE NO ALLEGATIONS REPORTED. DOI: (B)(6) 2006 - DOR: (B)(6) 2006 (LEFT HIP). THIS PC IS FOR THE ALLEGATIONS AFTER FIRST REVISION OF THE LEFT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Fatigue; Hearing Impairment; No Code Available; Pain; Renal Failure

  MAUDE report 9519434 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR PAINFUL LEFT THA. CUP AND STEM REPORTED ON (B)(4). DOI: (B)(6) 2005; DOR: (B)(6) 2008; LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9519411 ↗
• InjuryApr 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH OPEN REDUCTION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8519568 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT HIP). PATIENT IS BILATERAL.

  Patient problems: Tissue Damage

  MAUDE report 8373680 ↗
• InjuryJul 9, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2018 - PRIMARY IMPLANT DATE: (B)(6) 2012. REVISION: POSSIBLE STEM LOOSENING AND POSSIBLE CAUSE OF PATIENT'S REPORT OF PAIN. LUCENT LINE ON X-RAY IMAGING ALONG THE PROXIMAL END OF STEM. GOOD BONE GROWTH EVIDENT IN DISTAL TWO THIRDS OF FEMORAL STEM. NIL SIGNS OF INFECTION. MALE PATIENT ID: (B)(6) YEARS; DOB: (B)(6).

  Patient problems: Pain

  MAUDE report 7669635 ↗
• InjuryMay 31, 2018Naturally Worn; Naturally Worn

  DER STATES THAT THE CUP WAS IN A VERTICAL POSITION. THE HEAD WORE THROUGH THE POLY, AND INTO THE RIM OF THE SHELL. WE REPLACED THE HEAD, CUP AND LINER. NO LOT NUMBERS WERE AVAILABLE FOR REMOVED IMPLANTS. DOI: (B)(6) 2009; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7558300 ↗
• InjuryMay 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP DEEP PROSTHETIC INFECTION AND CUP REVISION WITH SCIATIC NEUROLYSIS. REVISION NOTES REPORTED OF FAIR DEGREE METALLOSIS AND ALSO REPORTED THAT A SCANT AMOUNT OF FLUID WAS SENT OUT OF CULTURE WHICH APPEARED CLEAR, WITHOUT EVIDENCE OF INFECTION. IT WAS ALSO REPORTED THAT SEVERAL CULTURES OF HIP DID NOT REVEAL ANY POSITIVE GROWTH AND THERE WAS A FAIR DEGREE OF METALLOSIS AGAIN WITH CLOUDY-APPEARING FLUID BOTH SUPERFICIAL AND DEEP TO HIS FASCIA , PARTICULARLY IN THE ACETABULAR COMPONENT. THE ACETABULAR COMPONENT HAD SOME LONG-TERM WEAR SECONDARY TO THE METAL HEAD ARTICULATING WITH IT LONG TERM WHEN HE STILL HAD THE MISPLACED METAL LINER. DOI: (B)(6) 2010; DOR: (B)(6) 2011; RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation; Not Applicable; Tissue Damage

  MAUDE report 7544842 ↗
• InjuryDec 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION HIP: SURGEON - (B)(6), (B)(6) 2017. PRIMARY IMPLANT (B)(6) 2011. REVISION FOR; MULTIPLE DISLOCATIONS POST MECHANICAL FALL. LINER EXCHANGED FOR A CAPTIVE HEAD SYSTEM. FEMALE, (B)(6). RELATED PRODUCT: UNKNOWN JRN: L20301 - CORAIL KHO10 WITHOUT COLLAR STEM, LOT # 5039282. RELATED PRODUCT: UNKNOWN JRN: (B)(4) - DUOFIX SECTOR 56MM CUP PINNACLE, LOT # E5RFY1.

  Patient problems: Joint Dislocation

  MAUDE report 7142297 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: 2009 DOR: (B)(6) 2017 UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 7133288 ↗
• InjuryJul 19, 2017Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING.

  Patient problems: No Information

  MAUDE report 6725593 ↗