PINNACLE ALTRX 1221-36-256Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295393184), received between Jul 23, 2018 and Nov 27, 2024 — classified as 22 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2014; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20798548 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19549138 ↗
• InjuryJun 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REMOVAL/REPLACEMENT OF HEAD AND LINER DUE TO PATIENT DISLOCATING. PINNACLE DUAL MOBILITY IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 19521676 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022; DATE OF REVISION: (B)(6) 2022; (LEFT HIP). TREATMENT: HEAD AND LINER WERE REMOVED.

  Patient problems: Abscess; Fever; Inflammation; Pain; Unspecified Infection

  MAUDE report 15214759 ↗
• InjuryJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD RIGHT THR ON (B)(6) 2022. PATIENT DISLOCATED SAME DAY AS SURGERY AND ROTATED ACETABULAR CUP. REVISION WAS REQUIRED BY DR TO REMOVE CUP, LINER AND HEAD, AND PUT IN A MORE CONSTRAINED OPTION. REASON FOR DISLOCATION IS UNKNOWN BY SURGEONS. DOI: (B)(6) 2022. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14713761 ↗
• InjuryJun 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS CONVERSION TO CONSTRAINED DUE TO MULTIPLE DISLOCATIONS. REPLACED LINER AND HEAD. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14575961 ↗
• InjuryFeb 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF LEFT HIP ACETABULAR COMPONENTS AND FEMORAL HEAD COMPLETED DUE TO REPEATED DISLOCATION. PREVIOUS REVISION HISTORY UNKNOWN HOWEVER PREVIOUS REVISIONS WERE COMPLETED. BILATERAL DISLOCATION BELIEVED TO BE ASSOCIATED WITH A FALL ALTHOUGH PERSISTENT HISTORY OF CHRONIC DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 13577983 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED THEIR PRIMARY REPLACEMENT BACK IN 2017 (PINNACLE CUP WITH STRYKER RESTORATION MODULAR STEM AND FEMORAL HEAD). PATIENT PRESENTED AT HOLLYWOOD PRIVATE HOSPITAL YESTERDAY MORNING WITH SEVERE PAIN AND INFLAMMATION IN THE RIGHT HIP, UPON FURTHER INVESTIGATION IT WAS DECIDED THAT THE PATIENT WAS INFECTED AND NEEDED URGENT SURGERY. PLAN A WAS TO REMOVE THE PINNACLE LINER AND STRYKER FEMORAL HEAD AND REPLACE THESE WITH A PINNACLE DM WITH NEW STRYKER FEMORAL HEAD IN CONJUNCTION WITH A DEBRIDEMENT AND WASH OUT. PLAN B WAS TO PERFORM A WASHOUT AND DEBRIDEMENT, REPLACE THE LINER AND HEAD AS A TEMPORARY SOLUTION PRIOR TO A FULL STAGED REVISION ONCE BIOPSY RESULTS ARE RETURNED FROM TONIGHT'S CASE. UPON OPENING, THE SURGEON DETERMINED THE INFECTION WAS SEVERE, SO WE RAN WITH PLAN B. DOI: 2017; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 12882015 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Pain

  MAUDE report 12548544 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACEMENT OF A SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 11004575 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: OCT 26, 2020, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10815861 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CHANGED POLY LINER AND HEAD DUE TO INFECTION AND WASHOUT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10700243 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY PERFORMED HEAD AND POLY EXCHANGED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10665271 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED POLY, IRRIGATED AND DEBRIDED AND REPLACED POLY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9836564 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGED INFECTION AFTER THE FIRST REVISION. THE STEM WAS REPORTED IN (B)(4) FOR THE RIGHT HIP FIRST REVISION. DOI: (B)(6) 2010, (CUP, SCREW). DOI: (B)(6) 2016, (HEAD, LINER). DOR: NONE REPORTED, (RIGHT HIP). PLEASE SEE, (B)(4) (RIGHT HIP) FIRST REVISION, (B)(4) (LEFT HIP).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9355627 ↗
• InjuryNov 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT BROUGHT TO SURGERY FOR A HEAD AND LINER EXCHANGE FOR SEVERAL DISLOCATIONS. THE CUP WAS RETAINED AND A NEW LINER WAS PLACED TO ENHANCE STABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9319512 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 8276988 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF STEM AND SHELL AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8169409 ↗
• InjuryOct 23, 2018Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  REVISION DUE TO DISLOCATION AND INSTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 7996276 ↗
• InjurySep 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7905121 ↗
• InjuryJul 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT CAME INTO THE DOCTOR'S OFFICE COMPLAINING OF A SQUEAKING HIP. UPON XRAY REVIEW, IT WAS DETERMINED THAT THE LINER WAS SEPARATED FROM THE SHELL. IT IS NOT KNOWN IF THE LINER WAS NOT LOCKED IN PROPERLY OR IF IT RELEASED POST OP, THE PATIENT HAD BEEN IN A MVA AND HAD A FEMORAL ROD PLACED IN THE FEMUR AND REMOVED IN A SEPARATE PROCEDURE PRIOR TO THE PRIMARY HIP SURGERY. THERE WAS A LOT OF SCARRING AND THE HIP WAS VERY TIGHT. BOTH THE PRIMARY AND REVISIONS WERE DIFFICULT DUE TO THESE FACTORS. WE WERE ABLE TO REPLACE THE HEAD AND LINER DURING THE REVISION AND THE DOCTOR SEEMED HAPPY WITH THE RESULT. THE LINER WAS RETAINED BY THE PATIENT. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Scarring

  MAUDE report 7718291 ↗
• InjuryJul 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO SURGEON SEEKING A SECOND OPINION FOR HIS LEFT TOTAL HIP DONE AT (B)(6) HOSPITAL. PATIENT'S PRIMARY COMPLAINT WAS PAIN. ORIGINAL SURGERY WAS DONE USING A POSTERIOR APPROACH, +15.5 HEAD AND A LIPPED LINER. SURGEON DETERMINED THE PATIENT WAS LEFT WITH A LEG TOO LONG AND TIGHT. SURGEON ELECTED TO REVISE THE HEAD, LINER, AND CUP. IMPLANTS WERE WELL FIXED WITH NO LOOSENING. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Pain

  MAUDE report 7709977 ↗