PINNACLE 1218-36-760Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295012177), received between Dec 21, 2017 and Dec 16, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 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, HEAD/LINER EXCHANGE. NO ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 23815346 ↗
• 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 22018401 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS LEFT TOTAL HIP DONE WITH A RECLAIM STEM AND PINNACLE CUP WITH CONSTRAINED LINER. PATIENT WAS SHOWING SIGNS OF INFECTION AND WAS BROUGHT IN FOR I&D WITH HEAD AND LINER EXCHANGE. THERE WAS NO DELAY IN SURGERY OR MENTION OF PRODUCT COMPLICATIONS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21699924 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT PATIENT HAD AN INFECTED TOTAL HIP. WASHED OUT AND EXCHANGED CONSTRAINED LINER THAT WAS SWAP OUT ON (B)(6) 2021. ALSO EXCHANGED SROM FEMORAL HEAD THAT WAS IMPLANTED (B)(6) 2017 AT (B)(6) BY DR. (B)(6). DOI: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12473647 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP DUE TO RECURRENT INFECTION. SCREWS WERE REMOVED AND REPLACED TO SEE IF INFECTION TRAVELED BEHIND THE SHELL. SCREWS WERE IMPLANTED ORIGINALLY ON (B)(6) 2017. DOI: (B)(6) 2021; DOR: (B)(6) 2021: LEFT HIP.

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

  MAUDE report 11719980 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP I&D DUE TO INFECTION. DOI: (B)(6) 2017, DOR: (B)(6) 2021, LEFT HIP.

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

  MAUDE report 11236517 ↗
• InjuryJun 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PINNACLE CONSTRAINED CIP PLACED IN 2013. ON (B)(6) 2020 SHE DISLOCATED HER RIGHT HIP. SHE WAS BROUGHT TO SURGERY AND THE HEAD AND LINER WERE REPLACED. ALL THE CUP SCREWS WERE ALSO REMOVED. DOI: (B)(6) 2013. DOR:(B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10114319 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR AFTER FIRST REVISION. DOI: (B)(6) 2012. DOR: NONE REPORTED. RIGHT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9046045 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS AND ABDUCTOR MUSCLE REPAIR AFTER FIRST REVISION. DOI: (B)(6) 2011. DOR: (B)(6) 2013; RIGHT HIP. PATIENT HAS BILATERAL HIP IMPLANTS. (B)(4) FOR LEFT HIP.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8743972 ↗
• InjuryApr 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. WASH OUT WAS DONE. LINER AND HEAD WERE CHANGED. DOI: UNKNOWN; DOR: (B)(6) 2018.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7439374 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7138205 ↗