PINNACLE ALTRX 1221-44-462Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295016663), received between Sep 21, 2018 and Nov 18, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON 05/15/2012 PATHOLOGY REPORT SHOWS SEVERAL OF THE FRAGMENTS ARE NECROTIC IN APPEARANCE, ONE OF THE FRAGMENTS SHOWS CHRONIC INFLAMMATORY CELLS ON (B)(6) 2012, THE PATIENT HAD AN EXTENDED FEMORAL OSTEOTOMY, REMOVAL OF TOTAL HIP COMPONENTS INCLUDING BOTH FEMORAL AND ACETABULAR COMPONENTS, IMPLANTATION OF CEMENT SPACER WITH ANTIBIOTICS TO ADDRESS PROBABLE INFECTION IN THE LEFT HIP. PATIENT WAS REPORTED TO HAVE HAD PAIN. PRIOR TO THIS REVISION, THE PATIENT HAD SEVERAL INJECTIONS TO ATTEMPT TO ALLEVIATE THE PAIN WITH LIMITED SUCCESS. DURING THIS REVISION SURGERY, THE SURGEON OBSERVED SILVER DISCOLORATION TO THE JOINT FLUID. ALL COMPONENTS WERE REVISED DUE TO THE PROBABLE INFECTION. AN EXTENDED OSTEOTOMY WAS REQUIRED TO REMOVE THE WELL-FIXED FEMORAL STEM. (NO MENTION OF THE MANUFACTURER OF THE COMPONENTS REMOVED OR THE COMPONENTS IMPLANTED IN THE CURRENT MEDICAL RECORDS). CEMENT SPACERS WERE PLACED DURING THIS PROCEDURE. (B)(4). ON (B)(6) 2012, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY, REIMPLANTATION AND FINISHING OF THE SECOND STAGE, TO ADDRESS POST INFECTED LEFT TOTAL HIP ARTHROPLASTY. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS TROCHANTERIC

  Patient problems: Metal Related Pathology; No Code Available; Test Result; Unspecified Infection

  MAUDE report 9337458 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION. DOI: (B)(6) 2011, (HEAD AND LINER); DOR: (B)(6) 2012 (LEFT HIP). DOI: (B)(6) 2008, (CUP, SCREWS, STEM, AND SLEEVE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9162994 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUN 27, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, LACK OF MOBILITY AND LEG DISCREPANCY THAT RESULTED TO ROTOSCOLIOSIS, AND LOWER BACK PAIN. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS TRUNNIONOSIS WITH METAL DEBRIS. PATIENT WAS NOTED TO HAVE SIGNIFICANTLY ELEVATE METAL IONS. REVISION NOTE STATED THAT THERE WAS A SIGNIFICANT SCARRING BETWEEN ILIOTIBIAL BAND AND VASTUS LATERALIS, FLUID FROM THE HIP, CHRONIC GRANULOMATOUS TISSUE NOTICED IN THE PERICAPSULAR TISSUE. IT WAS ALSO STATED THAT THERE WAS A METAL WEAR AND DAMAGE TO THE SUPERIOR HALF OF THE FEMORAL TAPER CONSISTENT WITH GALVANIC AND CREVICE CORROSION AND DAMAGE TO THE TAPER ON THE FEMORAL HEAD. CLINIC NOTES INDICATE SOME EDEMA AROUND THE LEFT HIP. THERE ARE NO LAB VALUES PROVIDED FOR THE REPORTED ELEVATED METAL IONS. REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY DETERMINED THAT NO INDICATION OF POLYETHYLENE LINER BEARING WEAR WAS REPORTED. ADDITIONALLY, AS NO REPORT WAS MADE FOR PSEUDOTUMOR, METALLOSIS, OR ALVAL WITHIN RECORDS, ONLY THE NON-SPECIFIC CHRONIC GRANULOMATOUS TISSUE, THE ADVERSE TISSUE REACTION HARM IS NOT SUPPORTED. BOTH OF THE

  Patient problems: Edema; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Scarring; Test Result

  MAUDE report 9139633 ↗
• InjuryJul 11, 2019Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  OFFICE NOTES (B)(6) 2007 INDICATE THE PATIENT IS EXPERIENCING PAIN, POPPING, AND LOCKING FEELINGS WITHIN THE RIGHT HIP. RADIOLOGY REPORT (B)(6) 2008 INDICATES THE PATIENT HAS A RIGHT TOTAL HIP WITH EVIDENCE OF BONE FRACTURE. FINDINGS FROM THE RADIOLOGY IMAGES INCLUDE THAT THE PATIENT IS STATUS POST TOTAL RIGHT HIP ARTHROPLASTY WITH FIXATION PLATE AND SCREWS TRANSFIXING AN ACETABULAR FRACTURE.

  Patient problems: Ambulation or Postural Difficulties; Embolism/Embolus; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation; Joint Laxity; Pain; Pulmonary Embolism; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8780664 ↗
• InjuryMay 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR MIGRATION / LOOSENING OF THE ACETABULAR SHELL. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. REVISION OF SHELL, LINER AND HEAD HAS OCCURRED. DOI: (B)(6) 2012; DOE: (B)(6) 2016; DOR: (B)(6) 2016; (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 8660242 ↗
• InjuryApr 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES LOOSENING OF CUP, DISLOCATION AND INFECTION AFTER FIRST REVISION (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 8539914 ↗
• InjuryNov 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8114955 ↗
• InjurySep 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS IN BLOOD. HEAD AND LINER WAS REVISED. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7897433 ↗