PINNACLE ALTRX 1221-32-452Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295016298), received between Aug 3, 2017 and Sep 30, 2021 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2021, (UNKNOWN SIDE).

  Patient problems: Joint Laxity

  MAUDE report 12554947 ↗
• InjuryJul 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON OPENED THE CAPSULE HE SAW THE LINER WAS DISASSOCIATED FROM CUP. PATIENT CAME IN WITH STABILITY ISSUES. BROWN REVISED HEADBALL AND LINER. EXTRACTED LINER DIDN¿T APPEAR TO HAVE SCREW HEAD MARKS. IMPLANTS ARE NOT AVAILABLE FOR REVIEW. DOI: (B)(6) 2021. DOR: (B)(6) 2021. (RIGHT HIP).

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

  MAUDE report 12196522 ↗
• InjuryFeb 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON EXPLAINED THAT THE PATIENT WAS SUFFERING FROM DISLOCATION. UPON LOOKING AT THE XRAYS, THE SURGEON WASN'T SURE IF HEWAS GOING TO JUST REVISE THE HEAD AND LINER, OR FULLY REPLACE THE ACETABULAR COMPONENTS. THE CUP APPEARED TO BE A LITTLE BIT VERTICAL ON XRAY. ONCE THE 32MM HEAD AND +4 NEUTRAL LINER WERE REMOVED, THE SURGEON WANTED TO TRIAL A 36MM +4 10 DEGREE LINER WITH A 36MM +8.5 HEAD OPTION. HE FOUND THIS TO BE STABLE AND OPTED TO JUST PERFORM THE HEAD AND LINER EXCHANGE. THE REAL IMPLANTS WERE OPENED AND IMPLANTED. THE LEG WAS REDUCED AND FOUND TO BE SATISFACTORY. THE CLOSING PROCESS BEGAN. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2021; (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 11329902 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 10945462 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD AND LINER WERE REMOVED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 10653492 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GRAM NEGATIVE INFECTION. REMOVAL OF ALL IMPLANTS AND ANTIBIOTIC SPACER INSERTED. ALL IMPLANTS ARE REMOVED, NOTHING RETAINED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10650183 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED LEFT HIP WOUND DEHISCENCE WITH SUPERFICIAL WOUND INFECTION. OPERATIVE NOTES INDICATED FAT NECROSIS. DOI: (B)(6) 2016 (LINER & HEAD); DOI: (B)(6) 2005 (CUP & STEM); DOE: (B)(6) 2016 LEFT HIP.

  Patient problems: Inflammation; No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9909824 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOTAL HIP REVISION OF POLY LINER AND FEMORAL HEAD.

  Patient problems: No Code Available; Test Result

  MAUDE report 9794834 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES ELEVATED METAL IONS. LINER IS NON-METAL AND STEM WAS ALREADY REPORTED. DOI: (B)(6) 2015; DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Hypoesthesia; Pain; Weakness

  MAUDE report 9545028 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, LACK OF MOBILITY, LACK OF STRENGTH, LACK OF FULL RANGE OF MOTION AND EMOTIONAL DISTRESS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO REVISION REPORTED. DOI: (B)(6) 2013; DOR: NONE REPORTED LEFT HIP.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9452500 ↗
• InjuryApr 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS A CHRONIC DISLOCATOR AND WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8567007 ↗
• InjuryJan 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8265202 ↗
• InjuryOct 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7924082 ↗
• InjuryApr 16, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO SEVERE WEAR ON THE ACETABULAR LINER. DOI: (B)(6) 2015; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable

  MAUDE report 7432742 ↗
• InjuryJan 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES RECURRENT DISLOCATIONS. HEAD AND LINER EXCHANGE. DOI: (B)(6) 2014; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7227364 ↗
• InjuryOct 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL DER STATES THAT THE PATIENT EXPERIENCED AE FOR INITIAL DISLOCATION- PATIENT DID NOT FALL. EVENT MEETS THE DEFINITION OF SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. REVISION DUE TO DISLOCATION OCCURED ON (B)(6) 2017. DEPUY LEFT LINER AND HEAD WERE REVISED. EVENT IS CONSIDERED RESOLVED. IT WAS ALSO REPORTED FOR AN AE EXPERIENCED HEMATOMA.

  Patient problems: Joint Dislocation

  MAUDE report 6921927 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL PARTS REMOVED. ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6763487 ↗