PINNACLE ALTRX 1221-40-164Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295393467), received between Sep 27, 2017 and Jan 8, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION DONE BECAUSE OF INFECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18463935 ↗
• InjuryJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER AND HEAD WERE THE ONLY ITEMS REMOVED FOR A REVISION. THERE WERE NO VISIBLE DEFECTS WITH THE IMPLANTS. THE PATIENT WAS DISLOCATING WHICH WAS THE REASON FOR THE REVISION SURGERY. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16183660 ↗
• InjuryOct 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS REMOVAL OF HEAD AND LINER. IT WAS REPLACED WITH A HEMI HEAD FOR BETTER STABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15589581 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SEPTIC HIP. WASHOUT WAS COMPLETED. HEAD AND LINER WERE EXCHANGED. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14490181 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT LT TOTAL HIP REVISED TO PROSTALAC SPACER DUE TO INFECTION. ORIGINAL LEFT TOTAL HIP (B)(6)2020. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 12469765 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. LINER AND HEAD WERE EXPLANTED AND REPLACED. PATIENT WANTS THE IMPLANTS. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8420660 ↗
• InjuryFeb 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON REVISED PATIENTS HIP FOR DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8302171 ↗
• InjuryJan 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES PATIENT DISLOCATED TWICE, FOUR MONTHS POST REVISION SURGERY. PATIENT WAS NOT IN PAIN PRIOR TO DISLOCATIONS. (B)(6) 2017; (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7224181 ↗
• InjurySep 27, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PFS ALLEGED WEAK. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED INSTABILITY WITH RECURRENT DISLOCATION ALONG WITH THE DEVELOPMENT OF SOME HETEROTOPIC OSSIFICATION RESIDING WITHIN THE HIP ABDUCTORS. OPERATIVE NOTES INDICATED HETEROTOPIC BONE FORMATION WITHIN THE ADDUCTOR MUSCULATURE. UPDATED PATIENT HARM. DOI: (B)(6) 2016 DOR: (B)(6) 2017 RIGHT HIP 2ND REVISION.

  Patient problems: Calcium Deposits/Calcification; Extraskeletal ossification; Foreign Body Reaction; Joint Dislocation; No Code Available; Pain; Tissue Damage; Weakness

  MAUDE report 6899778 ↗