PINNACLE ALTRX 1221-28-248Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295016021), received between Sep 29, 2020 and Jun 12, 2025 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON PERFORMED REVISION OF A PINNACLE LINER DUE TO DISLOCATION. THE HEAD WAS DISLOCATED FROM THE LINER. PATIENT HAD AN EXETER STEM WHICH WAS NOT REVISED. THE LINER WAS REMOVED WITH THE POLY EXTRACTOR, AND THEN THE CUP WAS CONVERTED TO PINNACLE DUAL MOBILITY. NEW EXETER +8 SKIRTED HEAD WAS IMPLANTED, THE PATIENT HAD A +0 PREVIOUSLY.

  Patient problems: Joint Dislocation

  MAUDE report 22194509 ↗
• MalfunctionMay 7, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUP WAS IMPLANTED AND FELT LIKE HAD GOOD FIXATION, HOLE ELIMINATOR WAS IMPLANTED AND DEFINITIVE 28X48 LIPPED LINER WAS IMPLANTED. UPON REDUCTION OF HIP FOR TRIALING THE CUP MOVED POSITION. WE REPOSITIONED AND ASSESSED AND SURGEON DECIDED THE FIXATION IF THE CUP WAS INADEQUATE. WE COULDN¿T REMOVE THE POLY LINER FROM THE CUP WITHOUT DESTROYING IT THUS WE OPENED A NEW ONE FOR A NEW CUP. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> ITEMS EXPLANTED , WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO,

  Patient problems: Insufficient Information

  MAUDE report 19258352 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HE PATIENT REQUIRED REVISION SURGERY TO WASH OUT HER INFECTED HIP JOINT AND REPLACE THE HEAD AND LINER COMPONENTS; BLOOD AND TISSUE PATHOLOGY TESTS THE SURGEON SAID SHE WAS SHOWING SYMPTOMS OF INFECTION = PAIN AND INCREASED INFLAMMATORY MARKERS ON HER BLOOD TESTS. DOI: (B)(6) 2019; DOE: (B)(6) 2024.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 18748666 ↗
• InjuryAug 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP REVISION: THJR PATIENT CAME BACK TO THEATRE FOR A HEAD AND LINER EXCHANGE. THE PATIENT HAD THE HIP REPLACEMENT ON THE (B)(6) 2022. SURGEON SEEMS TO THINK HE DIDN'T IMPACT THE LINER IN PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 15232722 ↗
• InjuryJul 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A CORAIL PINNACLE THR DONE UNDER SPINAL ANESTHETIC ON (B)(6) 2022 AT (B)(6)HOSPITAL. SURGERY WAS UNEVENTFUL. PATIENT WAS RETURNED TO THE WARD. THEY WERE THEN TAKEN TO X-RAY A NUMBER OF HOURS LATER FOR A ROUTINE POST OP X-RAY. THE PATIENT WAS STILL UNDER THE INFLUENCE OF THE SPINAL ANESTHETIC & HER LEGS GOT CAUGHT IN THE BED SHEETS SO UNFORTUNATELY DISLOCATED HER HIP WHEN BEING MOVED FOR THE X-RAY. SURGEON WENT TO THE WARD AND DID A CLOSED REDUCTION. HIP WAS REDUCED BUT SURGEON WASN'T HAPPY WITH FEELING OF STABILITY HE HAD FELT ON THE TABLE, SO DECIDED TO BRING PATIENT BACK TO THEATRE FOR MUA UNDER IMAGE INTENSIFIER (I.I) TO DETERMINE IF FURTHER SURGERY WAS REQUIRED. ON EXAMINATION UNDER ANESTHETIC WITH I.I HE DECIDED THE PATIENT WOULD NEED TO BE OPENED SURGICALLY TO CHANGE THE HEAD & LINER. INSTRUMENTS WERE REPROCESSED AND THE PATIENT WAS BROUGHT BACK TO THEATRE. PLAN WAS SURGEON WANTED TO CHANGE FROM A 50X28MM LIPPED LINER AND 28+1.5 HEAD TO A 50X32MM NEUTRAL LINER WITH A LONGER 32MM HEAD. HE FELT THERE MAY BE SOME LEVERING ON THE LIP OCCURRING CAUSING THE FEELING OF INSTABILITY & FELT A 32MM DIAMETER WOULD GIVE MORE STABILITY WITHOUT NEEDING THE LIP. ON EXPOSING THE H

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 14978047 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND WERE REVIEWED: REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP SURGICAL EXCISION DUE TO PAIN, LIMITED RANGE OF MOTION, STIFFNESS AND HETEROTOPIC OSSIFICATION. THE SURGICAL EXCISION OF HETEROTOPIC OSSIFICATION ALONG WITH IRRIGATION AND DEBRIDEMENT WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. NO IMPLANTS WERE REVISED.

  Patient problems: Extraskeletal ossification; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10656686 ↗
• InjurySep 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10601070 ↗