PINNACLE Hip Solutions 1218-52-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295520276), received between May 25, 2021 and Sep 11, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to revision poly exchange for excessive poly wear.DOI: Unknown.DOR: Unknown.Affected side: Left.

  Patient problems: Insufficient Information

  MAUDE report 50732526 ↗
• InjuryJan 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24115708 ↗
• InjuryDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL AND DISLOCATED HIP. REVISED CUP FOR STABILITY. RETAINED STEM. NO IMPLANT FAILURE. NO LOOSENING. ALL PIECES RETRIEVED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23682584 ↗
• InjurySep 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND CONVERTED TO A CONSTRAINED LINER. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 23027271 ↗
• InjuryJun 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS HAVING TROUBLE WITH STABILITY/DISLOCATIONS DESPITE CORRECTLY POSITIONED IMPLANTS. SURGEON REMOVED DUAL MOBILITY CONSTRUCT AND PUT A CONSTRAINED CONSTRUCT IN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22292330 ↗
• MalfunctionMay 2, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ITEM PACKAGING WAS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953269 ↗
• InjuryJan 3, 2025Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION, CUP WAS TOO RETROVERTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21067716 ↗
• InjuryOct 8, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH DRAINAGE POST THA AFTER BEING DIAGNOSED WITH UNCONTROLLED DIABETES. PATIENT ALSO HAS CIRRHOSIS OF THE LIVER. AN I&D WITH MODULAR COMPONENT EXCHANGE WAS PERFORMED WITHOUT DELAY NOR PATIENT HARM. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 20400224 ↗
• InjuryMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT COMPLAINS OF REPEATED DISLOCATIONS. CUP REVISION PLANNED WITH COMPETITIVE COMPANY. CUP FOUND TO HAVE EXCESSIVE ANTEVERSION ACCORDING TO OPERATING SURGEON. CUP THEN FOUND TO BE LOOSE AT NON-CEMENTED INTERFACE ONCE ATTEMPTING TO USE CUP CUTTER. EXPLANTED SHELL SHOW NO OSTEOINTEGRATION. THERE WAS NO DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19220873 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION AND NEW IMPLANTS WERE IMPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18987443 ↗
• InjuryMar 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT RECEIVED A THA (B)(6) 2024 AFTER A NAIL REMOVAL THAT CUT THROUGH THE FEMORAL HEAD. PATIENT FELL ON 2/16 AND DISLOCATED HER HIP. THEY WERE NOT ABLE TO REDUCE IN THE ED SO BROUGHT BACK TO OR. APPEARED STEM SUBSIDED FROM FALL AND WAS LOOSE. STEM AND DUAL MOBILITY WAS REVISED TO CEMENTED ENDURANCE STEM AND CONSTRAINED LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18893525 ↗
• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 18490228 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17603181 ↗
• InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION DUE TO A DISLOCATION AND WAS CONVERTED TO A CONSTRAINED LINER. SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17572582 ↗
• InjuryAug 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. NO SURGICAL DELAY. DOI: UNKNOWN. DOR:(B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17442726 ↗
• InjuryJun 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17125329 ↗
• InjuryApr 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED WITH HIP DISLOCATION AND WAS OUT FOR A WEEK SO THE LEG WAS VARY CONTRACTED. SURGEON FIRST STARTED BY REMOVING DUAL MOBILITY AND PUTTING IN A CONSTRAINED LINER TRIED TO REDUCE A 32 +5 HEAD BUT WITH THE LEG BEING CONTRACTED, IT WAS UNABLE TO GET THE HIP REDUCED , THEN TRIED A 32 +1 HEAD AND AFTER MANY ATTEMPTS. SURGEON FINALLY REDUCED THE HIP BUT CRACKED THE TOP OF THE CONSTRAINED LINER, AFTER 30 MINUTES OF REMOVING THE CONSTRAINED LINER SURGEON WENT WITH A 36 +4 10* LINER AND 36 +8.5 HEAD. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16815099 ↗
• InjuryDec 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A PINNACLE DUAL MOBILITY HIP REPLACEMENT. IT WAS DISCOVERED POST OP THAT THE METAL LINER WAS NOT SEATED PROPERLY. PATIENT WAS BROUGHT BACK AND LINER WAS FIXED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 15906614 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE HIP. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15283689 ↗
• InjuryAug 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S GREATER TROCHANTER WAS BROKEN FROM A PRIOR OPERATION AND THE HIP HAD BECOME UNSTABLE AND DISLOCATED. SURGEON ELECTED TO PLACE A CONSTRAINED LINER. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15208866 ↗
• InjuryJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CONVERTED FROM PINNACLE DM TO CONSTRAINED LINER, CHRONIC DISLOCATER. EXPLANTED DM LINER, PE LINER AND HEAD. THERE IS NO REPORTED LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 14715948 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12563111 ↗
• InjurySep 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A PAINFUL LEFT HIP. RECURRENT DISLOCATION. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2021, (LEFT HIP).

  Patient problems: Joint Dislocation; Pain

  MAUDE report 12521303 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A CONSTRAINED LINER AND HEAD FOR STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11876798 ↗