PINNACLE 1219-32-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295013938), received between Nov 8, 2017 and Jan 30, 2026 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS A PINNACLE CUP WHERE IT IS TO BE REPLACED. WE WILL ORDER A SO-CALLED DUAL MOBILITY CUP BECAUSE THE PATIENT DOES NOT HAVE A STABLE HIP. REVISION SURGERY HAS NOT YET OCCURRED

  Patient problems: Joint Laxity

  MAUDE report 24220178 ↗
• InjuryNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HIP SURGERY AND CAME BACK AFTER 8 WEEKS BECAUSE THE LINER HAD LUXADED OUT OF THE CUP. PATIENT WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 23623827 ↗
• InjuryJul 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PINNACLE LINER DISASSOCIATION. THERE WAS LOOSENING OF THE LINER AT THE NON CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22506088 ↗
• InjurySep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISASSOCIATION OF LINER TO DM. ALL PARTS WERE RETRIEVED. THERE WAS NO CASE DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20248480 ↗
• InjuryMay 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING, SO SURGEON REMOVED THE CUP, LINER, AND HEAD BALL. REPLACED WITH ANOTHER VENDORS CUP AND LINER, AND EXCHANGED OUR HEAD BALL. KEPT ORIGINAL STEM. NO INFECTION WAS PRESENT. NO LOT NUMBERS AVAILABLE. NO DELAY IN SURGERY. PRODUCTS WERE NOT LOOSE, JUST REMOVED AND REPLACED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19359326 ↗
• InjuryJun 28, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? -> NO B. WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. -> REVISION WITH HEAD AND INLAY CHANGE. C. WAS THERE ANY ALLEGATION AGAINST THE CUP? -> NO.

  Patient problems: Pain

  MAUDE report 17216037 ↗
• InjuryJun 7, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PATIENT UNDERWENT REVISION SURGERY DUE TO PINNACLE LINER DISSOCIATION/BREAKAGE. DID THE EVENT OCCUR DURING STERILE PROCESSING? NO, DID THE EVENT OCCUR DURING FIELD INSPECTION? NO, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? LUXATION ,PAIN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IF YES, DESCRIBE :PATIENT NEEDED REVISION SURGERY, IS THE PATIENT PART OF A CLINICAL STUDY :NO, IP-(B)(4). DEVICE PROPERTY OF :HOSPITAL, DEVICE IN POSSESSION OF :AAM. 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: Pain

  MAUDE report 17078175 ↗
• InjuryMay 1, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PATIENT HAD A TOTAL HIP REPLACEMENT DONE 14 YEARS AGO WITH CORAIL/PINNACLE COMPONENTS. RECENTLY THE PATIENT FALL AND SIMULTANEOUSLY FELT A ¿POP¿ IN THEIR HIP REGION. PATIENT FELT SOMETHING WASN¿T QUITE RIGHT IN THEIR HIP FROM THAT POINT ON, AND WENT TO SEE THEIR SURGEON. SURGEON TOOK X-RAYS AND X-RAYS SHOWED WHAT APPEARED TO BE A LINER DISSOCIATION. PATIENT WAS BOOKED FOR REVISION SURGERY. REVISION SURGERY TOOK PLACE ON (B)(6) 2023 AND SURGEON FOUND THAT THE LINER (1219-32-058) HAD DISSOCIATED. SEVERAL OF ANTI-ROTATION TABS HAD SHEARED OFF. SURGEON THEN REVISED THE CONSTRUCT BY CEMENTING IN A DIFFERENT ACETABULAR LINER INTO THE ACETABULAR SHELL, (WHICH WAS WELL FIXED AND NOT DAMAGED), AND REPLACING THE FEMORAL HEAD ON THE WELL-FIXED STEM. NO ADDITIONAL INFORMATION IS AVAILABLE. . THANK YOU. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? SOMETHING DID NOT FEEL RIGHT IN THEIR HIP JOINT AFTER THE FALL TOOK PLACE., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: REVISION SURGERY WAS REQU

  Patient problems: Fall

  MAUDE report 16845102 ↗
• MalfunctionAug 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  T WAS REPORTED THAT "THE PURPOSE OF THIS LETTER IS TO REQUEST INFORMATION ABOUT YOUR EQUIPMENT THAT IS REPORTED TO HAVE BEEN USED IN A TOTAL HIP ARTHROPLASTY (THA) IN (B)(6) 2005. THE NEXT 15 YEARS THE HIP PROSTHESIS WORKED WELL, HOWEVER, IN 2020, PAIN WITH TROUBLE WALKING BECAME MY LIFE. AT PRESENT TIME THERE IS APPROXIMATELY 1.55MM SUPERIOR MIGRATION OF THE FEMORAL HEAD. THE INFORMATION THAT IS REQUESTED IS: WHAT TYPE OF POLYETHYLENE WAS USED, WHAT IS THE LONG TERM WEAR EVALUATION, AND WHEN IS A REVISION SUGGESTED.".

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

  MAUDE report 15212077 ↗
• InjuryJul 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE INSERT DISLOCATION POST-OP. DOI: (B)(6) 2014; DOR: (B)(6) 2022; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15122086 ↗
• InjuryMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REPORTED TO (B)(6): "HIP-TEP LEFT SIDE ON (B)(6) 2021 IN (B)(6). PATIENT NOW IS TRANSFERRED BY AMBULANCE FROM THE (B)(6) CLINIC IN (B)(6). PRESENTATION THERE BECAUSE OF SUBLUXATION PHENOMENA AT THE LEFT HIP JOINT. HE HAD NEVER BEEN FREE OF DISCOMFORT SINCE THE OPERATION. ALWAYS WHEN CLIMBING STAIRS AND DURING CERTAIN MOVEMENTS AND LOADS, HE HAD HEARD A CREAKING NOISE AND HAD SLIGHT PAIN. SO FAR, HE HAS HAD THE FEELING THAT THE HIP JOINT HAS JUMPED OUT SIX TIMES, BUT THEN LOCATED BACK IN ON ITS OWN. YESTERDAY RENEWED SUBLUXATION PHENOMENON WHEN BENDING, THIS TIME WITH SEVERE PAIN, AGAIN SNAPPING BACK BY ITSELF. HE NOW HAS A CONSIDERABLE FEELING OF INSTABILITY AND DOES NOT DARE TO MAKE CERTAIN MOVEMENTS. NO PAIN AT REST. NO TRAUMA. RADIOLOGICAL DISLOCATION OF THE PE. REVISION OF HEAD AND INLAY ON (B)(6) 2022 IN (B)(6)." DOI: (B)(6) 2021. DOR: (B)(6) 2022. LEFT HIP.

  Patient problems: Discomfort; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 13719690 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ORIGINAL TOTAL HIP REPLACEMENT (WHICH WAS REVISED AS A STAGE 1 REVISION IN (B)(6) OF 2020), WAS DONE ON (B)(6) 2018. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 11983626 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN. DOI: (B)(6) 2013. DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11728397 ↗
• InjuryDec 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT IS DUE TO BE REVISED THIS WEEK BEGINNING THE (B)(6) 2020. CORAIL/PINNACLE THR (LEFT SIDE) IN (B)(6) 2012. 3-4 WEEKS AGO (MID (B)(6) 2020) ¿ STOPPED TO PICK SOMETHING UP FROM FLOOR ¿ SUDDEN GROIN PAIN ¿ WHICH SETTLED QUICKLY. NO ONGOING PAIN SINCE THEN. ONLY SQUEAKS WHEN WALKING AND USING STAIRS. AUDIBLE (CLASSIC) SQUEAK WHEN WALKING. PATIENT SHOWN HIS POST OP AND PREVIOUS FILMS AS COMPARED TO TODAY ¿ LINER DISSOCIATION NOTED AND EXPLAINED. GIVEN A PAIR OF CRUTCHES.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 10942487 ↗
• InjurySep 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS LINER DISASSOCIATION. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 10600819 ↗
• InjuryMay 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS FALLEN A FEW TIMES AND IS A MULTIPLE DISLOCATOR. PULLING THE LINER AND GOING TO A CONSTRAINED LINER WITH A HEAD EXCHANGE. NO COMPLAINTS OR PROBLEMS WITH OUR IMPLANTS. DOI: (B)(6) 2004; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10102770 ↗
• InjuryJan 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. SURGEON STATES PATIENT HAD DISLOCATED TWO TIMES (WITHIN PAST 6 MONTHS) AND WANTED TO CONSTRAIN THE HIP USING A PINNACLE ESC. DOCTOR EXPLAINED 32N 58 POLY AND +1 32 HEAD. DOCTOR DID NOT TRIAL CONSTRAINED 58+4N AND 36 1.5 METAL BUT IMPLANTED THEM, CHECKED RANGE OF MOTION, AND WAS SATISFIED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; UNKNOWN AFFECTED SITE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9629189 ↗
• InjuryDec 6, 2019Disconnection; Naturally Worn; Disconnection; Naturally Worn

  REVISION OF ACETABULAR COMPONENTS-PUT IN BY SAME SURGEON IN (B)(6) 2007. ON X RAY IT APPEARED THAT THE MARATHON LINER HAD COMPLETELY WORN DOWN, HOWEVER, ONCE THE HIP WAS EXPOSED, IT WAS APPARENT THAT THE LINER HAD COMPLETELY DISENGAGED FROM THE PINNACLE SHELL AND THE METAL HEAD WAS GRINDING ON THE SHELL. THE CORAIL STEM REMAINED IN SITU AS IT WAS WELL FIXED. ALL ACETABULAR COMPONENTS AND THE FEMORAL HEAD WERE REMOVED.

  Patient problems: No Code Available

  MAUDE report 9432226 ↗
• InjuryDec 6, 2019Naturally Worn; Naturally Worn

  58MM PINNACLE CUP, 32 NUETRAL LINER, SROM 32+6 HEAD REMOVED DUE TO LINER WEAR AND CUP WEAR. THE FEMORAL HEAD WORE THROUGH THE POLY LINER AND THE CUP THROUGH TO BONE.

  Patient problems: No Code Available

  MAUDE report 9425493 ↗
• InjurySep 17, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE ARDS HAVE SHEARED OFF FROM ONE SIDE OF THE LINER AND THE CERAMIC HEAD HAS METAL MARKINGS ON THE OUTER SURFACE. BOTH THESE EVENTS WOULD SUGGEST THAT THE LINER HAS DISASSOCIATED AND THAT THE HEAD WAS THEN IN CONTACT WITH THE SHELL.

  Patient problems: No Code Available

  MAUDE report 9079203 ↗
• InjuryJul 25, 2019Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  SURGEON REPORTED TO (B)(6): IMPLANTATION OF A CEMENTLESS HIP-TEP RIGHT SIDE IN (B)(6) 2012. NOW SPONTANEOUS INLAY LUXATION. REVISION OF INLAY AND HIP HEAD ON (B)(6) 2019.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Dislocation; No Code Available; Pain

  MAUDE report 8826845 ↗
• InjuryJan 10, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE PATIENT HAD PINNACLE LINER WAS DISASSOCIATED FROM THE ACETABULAR SHELL.

  Patient problems: No Code Available

  MAUDE report 8237919 ↗
• InjuryMay 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS REOCCURING DISLOCATION. DOI: 2004; DOR: (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7512017 ↗
• InjuryMar 13, 2018Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  COMPLAINT DESCRIPTION: DEPUY17-30.  IT WAS OCCURED A DISLOCATION OF THE PINNACLE MARATHON PE NEUTRAL LINER 32IDX58OD THAT WAS IMPLANTED IN 2011. THE EVENT WAS NOT LINKED TO ANY TRAUMA. IT WAS NECESSARY A NEW INTERVENTION.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7333620 ↗
• InjuryDec 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES PATIENT HAD A PREVIOUS RIGHT TOTAL HIP ARTHROPLASTY USING A PINNACLE CUP AND SUMMIT STEM. CUP INCLINATION MEASURES 42 DEGREES. PINNACLE LINER HAS SPONTANEOUSLY DISASSOCIATED 12 YEARS AFTER INITIAL SURGERY. PATIENT BROUGHT TO OR FOR A LINER AND HEAD EXCHANGE. DOI: 2005; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 7142366 ↗