PINNACLE 1218-32-754Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295012009), received between Aug 29, 2017 and Jul 10, 2026 — classified as 25 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 25779046 ↗
• InjuryNov 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO THE ESC LINER DISLOCATED WITHIN THE FEW MONTHS IT WAS IMPLANTED. IT WAS THEN REPLACED WITH ANOTHER ESC LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23607849 ↗
• InjuryJan 14, 2025Adverse 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 INFECTION. COMPONENTS WERE EXPLANTED AND REPLACED WITH THE EXACT SAME SIZE. THERE WAS NO HARM DONE TO THE PATIENT. THERE WAS NO SURGICAL DELAY IN THE CASE. PRODUCTS WERE DAMAGED UPON EXTRACTION. DOI: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21149854 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR RECALLED ST THE PRIOR CASE, NOT FEELING LIKE THE RING WAS PROPERLY SEATED OR THE PERIPHERAL POLY TABS WHERE COMPROMISED WHEN RING WAS IMPACTED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE- LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21113444 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20696375 ↗
• InjuryOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. REMOVED CUP AND WENT BACK. REVISION CUP AND ADDED MORE ANTEVERSION. NO ADDITIONAL INFORMATION. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20369895 ↗
• MalfunctionAug 22, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE LINER TRIAL BROKE DURING CASE. LINER WAS REMOVED, AND THE NON-LIPPED LINER WAS TRIALED INSTEAD. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038488 ↗
• InjuryApr 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO BROKEN CONSTRAINED LINER. THERE WAS NO LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19127140 ↗
• InjuryDec 21, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD WORN DOWN THE LOCKING MECHANISM ON THE CONSTRAINED LINER AND DISLOCATED. SURGEON ELECTED TO PLACE A DUAL MOBILITY CONSTRUCT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2014. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18377586 ↗
• InjuryOct 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED. INDICATES, THAT THE PINNACLE CUP WAS INSIDE THE PATIENT, BUT THE SURGEON DID NOT TOUCH THE CUP. IT STAYED INSIDE. HE JUST CHANGED, THE DEFECTIVE CONSTRAINED LINER.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 17919476 ↗
• MalfunctionJan 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT POLY TAB BROKE DURING REDUCTION. THERE WAS 15 MIN SURGICAL DELAY. DOE: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16184281 ↗
• InjuryDec 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15923923 ↗
• InjuryJul 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A CONSTRAINED LINER IMPLANTED IN (B)(6) 2017. SHE RECENTLY DESCRIBED "HIP INSTABILITY" TO SURGEON. SO HE DECIDED TO DO REVISION SURGERY ON (B)(6) 2022. X-RAY REVEALED THE LOCKING RING DIS-ASSOCIATED FROM THE LINER, SO SURGEON DID A LINER EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2017. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14957293 ↗
• InjuryJun 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS COMPLAINT IS TO CAPTURE THE ADDITIONAL INFORMATION RECEIVED FOR (B)(4) INSTRUMENT CASE: REVISION FOR DISLOCATION : RECLAIM STEM WAS UNABLE TO BE EXPLANTED DUE TO FAILED DISASSEMBLY INSTRUMENT. NO DEPUY PRODUCTS WERE EXPLANTED ON FEMORAL SIDE EXCEPT FOR CERAMIC HEAD WITH TITANIUM SLEEVE. NO DEPUY PRODUCTS WERE EXPLANTED ON FEMORAL SIDE EXCEPT FOR FEMORAL HEAD, RECLAIM STEM AND PROXIMAL BODY REMAINED IN SITU - LOT AND PRODUCT CODE OF FEMORAL HEAD UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14835619 ↗
• InjuryMay 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED HIP WITH PINNACLE CONSTRAINED LINER. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(4) 2022. DOR: (B)(4). 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14349528 ↗
• InjuryAug 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A DISLOCATED TOTAL HIP WITH CONSTRAINED LINER. THE HEAD PULLED THROUGH THE LOCKING MECHANISM, THE POLY REMAINED LOCKED INTO CUP. POLY WAS REMOVED AND A NEW POLY WAS INSERTED, SAME AS THE ONE WE REMOVED. LINER TOOK 25 MINS TO REMOVE. DOI: UNKNOWN, DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12281581 ↗
• InjuryMar 3, 2021Device Dislodged or Dislocated; Illegible Information; Device Dislodged or Dislocated; Illegible Information

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE DOCTOR SAID THE PATIENT DISLOCATED THEIR PROSTHETIC HIP. THE CONSTRAINING RING WAS LOOSE FROM THE LINER AND SHOWED SIGNS OF IMPINGEMENT (DENTED). POLY AND HEAD WERE REMOVED AND REPLACED. LOT NUMBERS WERE UNREADABLE UPON REMOVAL. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11405491 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT "IN (B)(6) 2019 I HAD HIP REVISION SURGERY, WHICH INCLUDED THE USE OF THE DEPUY CONSTRAINED ACETABULAR LINER. INITIALLY I DID NOT NOTICE ANY DIFFERENCE FROM MY PREVIOUS LINER. HOWEVER, AS THE MONTHS HAVE PASSED, I HAVE EXPERIENCED A CLICKING FEELING/MOVEMENT IN MY HIP WHEN I MOVE IN CERTAIN WAYS. FOR INSTANCE, WALKING UP STAIRS, I FEEL A CLICKING (FOR LACK OF A BETTER DESCRIPTION) WHEN I LIFT ON THE LEG WITH THE REVISION. ALSO, WHEN I BEND IN CERTAIN WAYS, GET UP FROM A SITTING POSITION AT TIMES, AND OTHER ACTIVITIES. SINCE I HAVE EXPERIENCED DISLOCATION IN THE PAST, I FIND THIS VERY DISCONCERTING. MY PREVIOUS DISLOCATIONS HAD NO ADVANCE ¿CLICKING¿, JUST THE DISLOCATION. MY DOCTOR HAS NOT PROVIDED ME WITH MUCH INFORMATION ON LIMITATIONS OF MY ACTIVITIES. IN FACT, THE LAST TIME I BROUGHT IT UP HE SAID ¿JUST BE HAPPY YOU CAN WALK¿. UNFORTUNATELY, I DID NOT PURSUE THE CONVERSATION AT THE TIME. I¿M SURE HE DOESN¿T KNOW WHAT I AM EXPERIENCING, SINCE IT SEEMS THIS IS NOT THE COMMON CONSTRAINER EXPERIENCE. MY QUESTION FOR YOU IS, CAN YOU PROVIDE ME WITH INFORMATION ON WHAT ONE SHOULD EXPECT AFTER THE CONSTRAINER HAS BEEN INSERTED? DOES IT MEAN THAT DISL

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 10991713 ↗
• InjuryMar 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT HAS A PINNACLE DPX CUP WITH CONSTRAINED LINER WITH A BIOMET STEM. THE PATIENT DID A DEEP SQUAT, AND THE HIP DISLOCATED OUT OF THE CONSTRAINED LINER. THE SURGEON ENDED UP REMOVING THE REVISION CUP TO CHANGE THE ANTEVERSION. THIS PATIENT DOES NOT HAVE ANY ABDUCTOR MUSCLES, SO IT IS DIFFICULT TO GET STABILITY. HE WAS ABLE TO ACHIEVE MODERATE STABILITY. IT IS UNKNOWN WHEN THE CUP AND LINER WERE IMPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9855872 ↗
• InjuryFeb 21, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  FRACTURE OF THE CONSTRAINING RING OF AN IMPLANTED PINNACLE® REVISION ACETABULAR CUP SYSTEM IN A CONDITION OF RECURRENT ANTERIOR LUXATIONS OF THE HIP PROSTHESIS. IN 2011 PRIMARY HIP-TEP, AFTER TWO REAR LUXATIONS IN 2014, REVISION TO THE ABOVE SYSTEM. AFTER A FALL IN (B)(6) 2019 AGAIN RECURRENT LUXATIONS. NOW ANOTHER REVISION IN (B)(6) 2020 WITH FRACTURE OF THE CONSTRAINING RING.

  Patient problems: Adhesion(s); Anemia; Bruise/Contusion; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Joint Dislocation; No Code Available

  MAUDE report 9739603 ↗
• InjuryDec 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD 2 DISLOCATIONS OF HIS HIP. UNABLE TO DO CLOSED REDUCTION SO THEY OPTED TO OPEN AND IMPLANT A CONSTRAINED LINER. THE RIM ON THE FIRST LINER WAS DAMAGED DURING REDUCTION SO THE SECOND CONSTRAINED LINER WAS IMPLANTED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9491179 ↗
• InjuryOct 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVE. PPF ALLEGED LOOSENING OF THE CUP, DISLOCATION, AND ELEVATED METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE LOOSENING OF ACETABULAR COMPONENT, SOFT TISSUE LOSS, METALLOSIS, AND DISLOCATION. OPERATIVE NOTE REPORTED OF MASSIVE SOFT TISSUE DESTRUCTION AND BROKEN 2 SCREWS. THERE WAS NO LOT NUMBER PROVIDED FOR THE BROKEN SCREWS. DOI: (B)(6), 201.2. DOR: (B)(6) 2016 (RIGHT HIP) FOURTH REVISION. (B)(4) (RIGHT HIP) 1ST REVISION. (B)(4) (RIGHT HIP) 2ND REVISION. (B)(4) (RIGHT HIP) 3RD REVISION.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Necrosis; No Code Available; Tissue Damage

  MAUDE report 9173199 ↗
• InjuryJun 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT DISLOCATED THERE HEAD FROM THE LINER WITHOUT THE RING THAT SECURES THE HEAD COMING FREE. SOMEHOW THE READ WAS ABLE TO BACK ITS WAY OUT WITHOUT THE RING COMING LOOSE. I DIDNT KNOW THAT WAS POSSIBLE. WE REMOVED THE LINER, RING AND HEAD AND REPLACED THE SHELL W A LARGER CUP, 40 MM LINER AND A 40MM BIPOLAR SHELL W 28MM-8.5 HEAD (POOR MANS TRIPOLAR).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8701175 ↗
• InjuryMar 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AND ELEVATED METAL IONS. DOI: (B)(6) 2015 - DOR: NONE REPORTED, (RIGHT HIP); DOI: (B)(6) 2008 (STEM).

  Patient problems: Joint Dislocation

  MAUDE report 8449002 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER PARTIALLY DISLOCATED FROM THE SHELL.

  Patient problems: No Code Available

  MAUDE report 8315321 ↗