PINNACLE 1219-32-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10603295014041), received between Aug 3, 2017 and Aug 24, 2026 — classified as 64 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (41 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 70 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Device Dislodged or Dislocated

  It was reported the patient underwent primary total hip arthroplasty for acetabular protrusion using a PINNACLE acetabular system and a CORAIL femoral stem. Unfortunately, three months after surgery, she was diagnosed with a severe medical condition, and approximately six months after the index procedure, she experienced two episodes of hip dislocation. Surgeon stated should another dislocation occur; revision surgery will be planned. The acetabular component orientation appears to be an important contributing factor tothe instability. Given the patient's significant comorbidities and the need to minimize the extent and morbidity of revision surgery, surgeon believes that conversion to a dual mobility construct may represent the safest and most appropriate option for patient.(b)(4) created to capture 2nd event with event date of (b)(6) 2026 and 1st event is captured in (b)(4) with event date of (b)(6) 2026.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 50406591 ↗
• InjuryJul 28, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent hip arthroplasty surgery in 2022. Components implanted were Corail femoral stem, 32mm +1 Articuleze metal head, 32/50 +4 10 degree Pinnacle Marathon acetabular liner, and 50mm Pinnacle Sector Gription shell. Surgery was completed successfully at the time. In late (b)(6) of 2026, patient notified the surgeon that they ¿had felt a pop in their hip region and hip felt odd¿. X-rays showed that revision surgery was necessary. During the hip revision surgery, the surgeon discovered that the acetabular liner was partially dissociated. The liner was partially dissociated in the posterior aspect. The surgeon then removed the partially dissociated liner and the previous femoral head. The liner was replaced with an ALtrex polyethylene one of identical dimensions. Surgeon also replaced the femoral head with a Biolox Delta Ceramic head of identical dimensions. The hip was then reduced and surgery finished successfully according to plan. No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50059958 ↗
• InjuryOct 24, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTED THAT "THE OPERATED HIP WAS FUNCTIONING WELL," BUT LOCALIZED PAIN WAS PRESENT ON THE ANTERIOR FACE OF THE THIGH AND ANTEROMEDIAL LEG, WITH AREAS OF HYPESTHESIA. ON (B)(6) 2023 THE PATIENT EXPERIENCED PAIN AND DIFFICULTY IN WALKING; HENCE RADIOGRAPH EXAM AND CT SCAN OF THE LEFT HIP WERE PERFORMED REVEALING A SUPERIOR DISLOCATION OF THE PROSTHETIC HEAD WITHIN THE ACETABULAR CAVITY, SUSPECTED DUE TO WEAR OF THE POLYETHYLENE SPACER. THE PATIENT WAS THEN ADMITTED ON (B)(6) 2023 WHERE DURING THIS PERIOD, THE PATIENT UNDERWENT ON A SURGICAL REVISION OF THE INSERT AND HEAD OF THE LEFT HIP PROSTHESIS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 23377773 ↗
• InjuryOct 21, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY AND DISLOCATION DUE TO POLY LINER WEAR. THE LINER AND HEAD WERE REMOVED. ORIGINAL IMPLANTATION DATE IS UNKNOWN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23348209 ↗
• InjurySep 11, 2025Fracture; Noise, Audible; Fracture; Noise, Audible

  IT WAS REPORTED THAT DURING THE PROCEDURE OF RIGHT HIP ENDOPROSTHESIS, PINNACLE, PINNACLE MARATHON ORAC CERAMIC HEAD BIOLOX DELTA WAS IMPLANTED. THE COURSE OF THE OPERATION AND REHABILITATION WAS UNCOMPLICATED. CONTROL X-RAYS WERE PERFORMED - ENDOPROSTHESIS ELEMENTS HEALED WITHOUT ANY SIGNS OF LOOSENING, PATIENT FUNCTIONED WELL UNTIL (B)(6) 2025, WHEN DURING WALKING THERE WAS DAMAGE TO THE POLYETHYLENE INSERT. FROM THAT MOMENT ON, THE PATIENT FELT THE CREAKING AND ACHING OF THE RIGHT HIP. ON (B)(6) 2025 THE REVISION PROCEDURE WAS PERFORMED AND THE DAMAGED INSERT AND HEAD WERE REPLACED.

  Patient problems: Discomfort

  MAUDE report 23031589 ↗
• InjuryAug 22, 2025Fracture; Fracture

  PATIENT HAD A PRIMARY LEFT THR DONE IN TWO YEARS AGO. PATIENT WITH HIGH BMI. THE X-RAY SHOWED AN ABNORMAL POSITION OF THE IMPLANT. SHE WAS REVISITED YESTERDAY 7.08.25. PATIENT WAS REVISED FROM A 32/50 MARATHON +4 10 DEG LINER TO A 28/50 MARATHON LIPPED LINER. THE CERAMIC HEAD WAS CHANGED FROM 32 +5 TO 28 +12 DELTA TS HEAD. NO SURGICAL DELAY. SEVERAL SPECIMENS WERE COLLECTED DURING SURGERY, INCLUDING ONE OF THEM WAS FOR METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 22877506 ↗
• InjuryAug 18, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF TOTAL HIP REPLACEMENT DUE TO SUSPECTED SUBLUXATION/INLAY DISLOCATION ON X-RAY. THE PATIENT COMPLAINED OF PAIN AND A FEELING OF INSECURITY AND HAD TO UNDERGO REVISION SURGERY WITH SUBSEQUENT REHABILITATION. INTRAOPERATIVELY, THERE WAS DISLOCATION OF THE INLAY AND FRACTURE OF THE INLAY. SURGEON PERFORMED INLAY REPLACEMENT, HEAD REPLACEMENT, MERETE NECK LENGTHENING. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22825855 ↗
• InjuryMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PINNACLE LINER WAS DAMAGED IN SITU, AND THE PATIENT NEEDED REVISION AS A RESULT.

  Patient problems: Insufficient Information

  MAUDE report 21976222 ↗
• InjuryJan 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CLAIMS THAT AS A RESULT OF THE PRODUCT, PATIENT EXPERIENCED PAIN AND WAS DIAGNOSED WITH HEMATOLOGICAL DISEASES CAUSED BY THE RELEASE OF METAL IONS. CONSEQUENTLY, PATIENT UNDERWENT REVISION SURGERY, ALTHOUGH FURTHER DETAILS OF THE SECOND SURGERY HAVE NOT BEEN PROVIDED. DOI: 2018. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21051844 ↗
• InjuryDec 5, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD SUDDEN ONSET OF HIP PAIN AND VISITED THE HOSPITAL. AN X-RAY WAS PERFORMED AND IT WAS FOUND THAT THE PRODUCT WAS BROKEN AND THE FIXATION FAILED. REPLACED WITH ANOTHER PRODUCT. REVISION WAS PERFORMED ON (B)(6) 2024. THERE WAS NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Pain

  MAUDE report 20852290 ↗
• MalfunctionOct 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024, THE POLYETHYLENE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20385572 ↗
• InjuryJul 19, 2024Naturally Worn; Naturally Worn

  CUP REVISION SURGERY AFTER 10 YEARS FROM IMPLANT.

  Patient problems: Foreign Body Reaction

  MAUDE report 19781982 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PARTIAL REVISION SURGERY OF YEAR 2023: INSERT DISLOCATION/MOBILIZATION. HEAD AND INSERT REPLACED. DOI: (B)(6) 2016. DOE: (B)(6) 2023.

  Patient problems: Loss of Range of Motion

  MAUDE report 19739627 ↗
• InjuryJul 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY TOOK PLACE TO REMOVE THE INSERT. WHEN REMOVED IT WAS FOUND BROKEN. DOI: (B)(6) 2023. DOE: (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19701794 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE VERTICAL CUP EVENTUALLY LED TO SUPERIOR POLY WEAR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19625245 ↗
• InjuryMay 17, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PATIENT LAWYER IS CLAIMING FOR COMPENSATION. THE PATIENT WAS IMPLANTED ON THE LEFT SIDE A TOTAL ENDOPROSTHESIS IN THE LEFT HIP JOINT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 19344860 ↗
• InjuryApr 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT KEPT DISLOCATING. EXCHANGED HEAD BALL AND DID A CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19013377 ↗
• InjuryDec 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION COMPLAINT RECEIVED. THE PATIENT HAD A HIP REVISION DUE TO JOINT PROSTHESIS IMPLANTATION FAILURE WITH A CONDITION OF MARKED METALLOSIS AND DISLOCATION OF THE ACETABULAR POLYETHYLENE. DOI: (B)(6), 2021. DOR: (B)(6), 2023. RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 18410846 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP THROMBUS. THIS CASE IS FROM THE HEALTH AUTHORITY. IT WAS REPORTED THAT ON THE FIRST DAY AFTER SURGERY, A FOLLOW-UP ULTRASOUND WAS PERFORMED ON THE LEFT LOWER LIMB BLOOD VESSELS. AT 22:37, IT WAS FOUND THAT THERE WAS A PARTIAL INTERMUSCULAR THROMBOSIS IN THE LOWER LEG OF THE LEFT LOWER LIMB. FOLLOWING THE DOCTOR'S ADVICE, THE LOWER LIMB PNEUMATIC PUMP TREATMENT WAS STOPPED, AND ONE TABLET OF RIVAROXABAN [J] [20MG] WAS CONTINUED ORALLY. THE PATIENT WAS ADVISED TO DRINK AT LEAST 2000ML OF WATER DAILY, AND TO CONTINUE TO STRENGTHEN ANKLE PUMP EXERCISE, QUADRICEPS MUSCLE RELAXATION AND CONTRACTION ACTIVITIES, AND OTHER REHABILITATION EXERCISES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18318857 ↗
• InjuryDec 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE POLY LINER IS FRACTURED. PATIENT STATUS/ OUTCOME / CONSEQUENCES. YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REQUIRED REVISION - HEAD AND LINER EXCHANGE, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01898905 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OFF NONE, IP-01898906 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE 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: Insufficient Information

  MAUDE report 18290860 ↗
• InjuryJun 21, 2023Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  SURGEON IS REPORTING AN INLAY LUXATION. PATIENT RECEIVED A HIP-TEP IN ANOTHER HOSPITAL ON (B)(6) 2020. A PE LIPPED LINER WAS INSERTED. SINCE (B)(6) 2023, THE PATIENT REPORTED CRUNCHING AND PAIN IN THE HIP WITHOUT TRAUMA. RADIOLOGICALLY, THE CASE APPEARED TO BE INLAY WEAR. HOWEVER, INTRAOP INLAY DISLOCATION WAS FOUND. THE INLAY WAS PLASTICALLY DEFORMED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17170450 ↗
• InjuryJun 1, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PATIENT UNDERWENT A THA (PINNACLE CORAIL WAX/POLY) IN 2018 AND THE IMPLANTS FAILED, POLYETHYLENE FRACTURE + CONTACT OF THE CERAMIC HEAD WITH THE METAL OF THE ACETABULAR IMPLANT. THE PATIENT COMPLAINED TO THE SURGEON ABOUT DISCOMFORT WHEN CARRYING OUT HIS DAILY ACTIVITIES, AS HIS PROSTHESIS WAS RIGID AND MAKING NOISE. THE LOOSENING OF THE POLYETHYLENE LINER OF THE ACETABULAR COMPONENT WAS DIAGNOSED. DURING THE REVISION PROCEDURE, BREAKAGE OF THE POLYETHYLENE ARDS (ANTI-ROTATIONAL DEVICES) WAS VERIFIED, WHICH PROMOTED THE LOOSENING AND EARLY DEFORMATION OF THE IMPLANT IN QUESTION. THE DOCTOR REPLACED THE DAMAGED COMPONENTS AND THERE WAS NO DAMAGE TO THE PATIENT. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 17039538 ↗
• InjuryMar 23, 2023Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  DURING THE ROUTINE RADIOGRAPHIC AND CLINICAL FOLLOW-UP, AN IMAGE COMPATIBLE WITH WEAR/BREAKAGE OF THE POLYETHYLENE OF THE IMPLANTED RIGHT TOTAL HIP PROSTHESIS WAS FOUND. A RECOMMENDATION FOR A RIGHT PTA INSPECTION WAS THEREFORE PLACED AND PERFORMED ON (B)(6) 2023 WITH A FINDING OF BROKEN, DISENGAGED AND DEFORMED POLYETHYLENE. THE CERAMIC HEAD IS ALSO WORN WITH INITIAL SIGNS OF METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 16597659 ↗
• InjuryFeb 9, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  CLAIM COMPLAINT RECEIVED AD 26 JAN 2023. CLAIM RECEIVED FROM KENNEDYS. REASON FOR REVISION POLYETHYLENE ENUCLEATION AND ALL THE ANCHORAGES WERE BROKEN. DOI: (B)(6) 2019. DOR: UNKNOWN. UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 16333306 ↗
• InjuryDec 19, 2022Fracture; Fracture

  THE PATIENT UNDERWENT RIGHT HIP PROSTHESIS REVISION SURGERY ON (B)(6) 2022, AS HE WAS UNDERGOING RADIOGRAPHIC AND CLINICAL FOLLOW-UP PERFORMED 5 YEARS AFTER HIP PROSTHESIS SURGERY ((B)(6) 2017). THE RUPTURE OF THE POLYETHYLENE INSERT WAS FOUND, AND THE CERAMIC HEAD WAS WORN, DEFORMED AND WITH INITIAL SIGNS OF METALLOSIS. DOI: (B)(6) 2017. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 16004476 ↗