PINNACLE 1218-36-660Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295012146), received between Dec 5, 2017 and Oct 23, 2025 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 16, 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.

• InjuryOct 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED THEIR RIGHT HIP. THE SURGEON REMOVED CONSTRAINED LINER AND IMPLANTED ANOTHER CONSTRAINED LINER, THIS TIME WITH A 10 DEGREE. PATIENT STATED THEY WERE SHAVING THEIR LEGS WHEN THE DISLOCATION OCCURRED. A COMPETITOR FEMORAL HEAD WAS ALSO EXCHANGED WITH LONGER NECK. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23372683 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR CHRONIC INFECTION. THE HEAD AND LINER WERE EXCHANGED AFTER WASHOUT AND THERE WAS ADMINISTRATION OF ANTIBIOTICS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22140414 ↗
• MalfunctionMay 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO CONSTRAINED LINERS BROKE DURING A CONVERSION OF A LINER TO A CONSTRAINED LINER. A DUAL MOBILITY WAS USED INSTEAD. THE SURGERY TOOK LONGER THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018456 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024 DOR- (B)(6), 2024 AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 20087012 ↗
• InjuryAug 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS DISLOCATED, LINER AND HEAD WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19975866 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A 20 TO 30-MINUTE SURGICAL DELAY IN ATTEMPTING TO SEPARATE THE BODY WHICH WAS UNSUCCESSFULLY DONE. NO REPORTS OF PATIENT HARM.

  Patient problems: Unspecified Infection

  MAUDE report 19615069 ↗
• InjuryNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT FELL AND DISLOCATED. THE ORIGINAL CUP SURGERY WAS ON (B)(6) 2021. THE ORIGINAL SYSTEM USED WAS A COMPETITOR STEM, SO ONLY THE CUP THAT WAS PUT IN ON (B)(6) 2021 WAS A DEPUY PRODUCT. ON (B)(6) 2021 THE PATIENT FELL AGAIN, AND THE DEPUY LINER WAS REVISED TO A CONSTRAINED LINER. CUP PLACEMENT IS GOOD, SO THE SURGEON IS IMPLANTING ANOTHER CONSTRAINED LINER. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18046693 ↗
• InjuryOct 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17869286 ↗
• InjuryJun 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN, DOR: MAY 22, 2023, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17050513 ↗
• MalfunctionFeb 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON FAILED TO REDUCE THE HIP UP AND OVER THE LIP OF THE CONSTRAINED LINER. AS A RESULT THE POLY BENT AND SNAPPED. WE HAD TO REMOVE IT AND USE ANOTHER LINER. REMOVING THE LINER ADDED 1 HOUR TO THE CASE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599768 ↗
• InjuryDec 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CONSTRAINED LINER DISASSOCIATED FROM PINNACLE CUP. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13010245 ↗
• InjuryDec 15, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  CONSTRAINED LINER DISASSOCIATED FROM PINNACLE CUP. DOI: (B)(4) 2021, DOR: (B)(4) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13010235 ↗
• InjuryNov 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATION AND CUP POSITION. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10792070 ↗
• InjuryDec 12, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PULLED OUT THE FEMORAL HEAD OUT OF THE PREVIOUS IMPLANTED CONSTRAINED LINER. EVERYTHING SEEMED TO BE OKAY WITH THE LINER. THE SURGEON REMOVED THE LINER AND REPLACED WITH A NEW CONSTRAINED LINER. DOI: (B)(6) 2019; DOR: (B)(6) 2019; UNKNOWN HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9457455 ↗
• InjuryOct 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED. DOI: (B)(6) 2011; DOR: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9227062 ↗
• InjuryApr 23, 2019Fracture; Difficult to Insert; Naturally Worn; Fracture; Difficult to Insert; Naturally Worn

  EVENT: A CONSTRAINED LINER DETAILED ABOVE WAS IMPLANTED SUCCESSFULLY INTO THE PINNACLE CUP AS PER SURGICAL TECHNIQUE, HOWEVER WHEN REDUCING THE FEMUR TO INTRODUCE THE FEMORAL HEAD INTO THE LINER IT WAS NOTED BY THE SURGEON THAT A SECTION OF THE LINER THAT SITS PROUD OF THE PINNACLE SHELL HAD DOUBLED BACK ON ITSELF AND IMPEDED THE FEMORAL HEAD FROM ENTERING THE CONSTRAINED LINER AND CAUSING DAMAGE TO THE CONSTRAINED LINER. IT WAS COMMENTED BY THE SURGEON THAT THE STRENGTH OF THE POLYETHYLENE SHOULD NOT ALLOW THIS TO HAPPEN. THE LINER HAD TO BE REMOVED ¿ WITH GREAT DIFFICULTY ¿ GREATER DAMAGE WAS CAUSED TO THE LINER ON REMOVAL AS A SECTION HAD TO BE CUT WITH OSTEOTOMES TO RELEASE IT FROM THE CUP. A NEW CONSTRAINED LINER WAS INSERTED AND SURGERY WAS COMPLETED. SURGERY TIME WAS EXTENDED BY 45 MINS APPROX.

  Patient problems: Not Applicable

  MAUDE report 8540291 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT HAD LEFT HIP ULTRASOUND-GUIDED ASPIRATION NON-JOINT CHECKED, WITH AN INDICATION OF METALLOSIS. MR. (B)(6) -SOFT TISSUE REPORTED LOCALIZED SWELLING AND PATIENT'S LEFT HIP OF RECURRENT AREAS WITH CONSISTENT METALLOSIS. IT WAS ALSO REPORTED THAT THERE IS A PRESSURE EROSION OF THE ISCHIAL TUBEROSITY. DOI: (B)(6) 2016; DOR: NOT REPORTED; LEFT HIP.

  Patient problems: Erosion; Swelling; Tissue Damage

  MAUDE report 8315779 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AFTER REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8070573 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT HAD RECURRENT SWELLING OF THE LEFT THIGH, AND LEG LIKELY TO SECONDARY TO PERSISTENT METAL ION REACTION. HE HAS ALSO HAD BALANCE ISSUES AS WELL AS INCREASED FATIGUE.

  Patient problems: Damage to Ligament(s); Fatigue; Host-Tissue Reaction; Limited Mobility Of The Implanted Joint; Necrosis; Osteolysis; Pain; Scarring; Swelling; Tissue Damage

  MAUDE report 7863684 ↗
• InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DID A DEBRIDEMENT AND SWAPPED THE HEAD AND LINER. NOTHING MALFUNCTIONING OR THOUGHT TO BE MALFUNCTIONING REGARDING DEPUY IMPLANTS. DOI: (B)(6) 2018 ; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7766984 ↗
• InjuryJul 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR; (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7654954 ↗
• InjuryMar 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION. DOI: (B)(6) 2018; DOR: (B)(6) 2018: LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7358149 ↗
• InjuryDec 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES INFECTION, SORENESS, PAIN AND DISCOMFORT, AND DEVICE FAILURE. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT HAD CUTANEOUS ABSCESS. CLINICAL NOTES REPORTED OF FEVER, CHILLS, WEAKNESS AND CUTANEOUS ABSCESS. DOI: (B)(6) 2015 - DOR: NOT REVISED (RIGHT HIP).

  Patient problems: Abscess; Fatigue; Fever; Unspecified Infection; Weakness

  MAUDE report 7084284 ↗