PINNACLE ALTRX 1221-32-252Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295016199), received between Jul 11, 2018 and May 7, 2026 — classified as 1 death, 16 injuries, 1 malfunction.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DOCTOR SWITCHED HEAD AND LINER TO GAIN STABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25110644 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24056672 ↗
• InjuryApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. HEAD AND LINER WERE REVISED TO A LONGER HEAD AND A 36 LINER. A 32 LIPPED LINER AND A 32 HEAD WERE REMOVED. PRODUCTS INFO WAS UNAVAILABLE. DOI: (B)(6) 3035. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21936642 ↗
• DeathJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON HAD A TOTAL HIP THAT HE PLANNED TO USE CORAIL PINNACLE FOR. TEMPLATED BEFORE THE CASE STARTED. FOLLOWED SURGICAL TECHNIQUE AND DISLOCATED FEMUR, RESECTED FEMORAL HEAD AND MOVED ONTO ACETABULUM. REAMED USING A SMALL REAMER, AND PROGRESSED IN SIZE USING EQUAL INCREMENTS OF 2. GOT TO SIZE 52 AND TRIALED. DEFINITIVE 52 CUP WAS OPENED. DRILLED AND MEASURED FOR SCREW PLACEMENT, USING APPROPRIATE DRILL BIT, GUIDE AND DEPTH GAUGE. 2 DEFINITIVE SCREWS OPENED (20MM AND 15MM). OPENED LINER 32MM BY 52MM LIPPED AND INSERTED AND IMPACTED AS PER TECHNIQUE. MOVED BACK TO FEMUR AND REAMED USING T-HANDLE STARTING WITH SIZE 8 AND GOING UP IN INCREMENTS OF . BROACHED STARTING AT SIZE 8, AND GOING UP IN INCREMENTS OF 1 TILL SIZE 11 BROACH FELT STABLE DOING APPROPRIATE CHECKS TRIALED STD 135 NECK AND 32 HEAD +5. TRIED TO REMOVE BROACH BUT GOT STUCK DISTALLY, REMOVED BROACH AFTER CHANGING INSTRUMENTS TO GAIN BETTER LEVERAGE. BROACH WITH A 12 AND HAD BETTER STABILITY. OPENED A DEFINITIVE STANDARD COLLAR 12 STEM AND 32 +5 HEAD. REDUCED PATIENT, CHECKED LEG LENGTH. SURGEON WAS HAPPY. NO CONCERNS OR ISSUES WERE NOTED. PATIENT DIED A FEW HOURS AFTER SURGERY, AFTER AN ATTEMPT TO MOVE THEM TO HOSPITAL T

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 19478407 ↗
• InjuryMar 18, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. YES ¿ TWO HIP REVISIONS. 2. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. 3. WHAT WAS THE REASON FOR THE PRIMARY REVISION AND SECONDARY SURGERY? LINER DAMAGE. 4. KINDLY CONFIRM WHY THE CUP WAS REVISED? WAS THERE ANY ALLEGATION AGAINST THE CUP? TO ELIMINATE THE ACETABULUM AS THE CAUSE OF LINER DAMAGE DOI: (B)(6) 2018, DOR: (B)(6) 2023, AFFECTED SITE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 18924255 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 18826988 ↗
• InjuryFeb 21, 2024Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED: 2. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT. 3. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. YES ¿ TWO HIP REVISIONS. 4. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. 7. WHAT WAS THE REASON FOR THE PRIMARY REVISION SURGERY? LINER DAMAGE. 8. WHAT WAS THE REASON FOR THE SECONDARY REVISION? LINER DAMAGE. 9. CAN YOU PLEASE CONFIRM IF THE PREVIOUS REVISION INVOLVES DEPUY PRODUCTS? YES. 10. KINDLY CONFIRM WHY THE CUP WAS REVISED. WAS THERE ANY ALLEGATION AGAINST THE CUP? TO ELIMINATE THE ACETABULUM AS THE CAUSE OF LINER DAMAGE

  Patient problems: Insufficient Information

  MAUDE report 18747010 ↗
• MalfunctionJun 22, 2023Improper or Incorrect Procedure or Method; Wrong Label; Improper or Incorrect Procedure or Method; Wrong Label

  IT WAS REPORTED THAT A LIPPED 28MM ID 52MM OD LINER WAS IN FACT INITIALLY USED, AND THE WRONG STICKER FOR A LIPPED 32MM ID 52MM OD LINER WAS PLACED IN THE NJR FORM FOR THE PATIENT. IT IS NOT CLEAR AS TO WHY THERE WAS A 32MM ID 52MM OD LINER STICKER IN THE THEATRE AT THE TIME OF THE SURGERY, HOWEVER THE HOSPITAL IS CARRYING OUT FURTHER INVESTIGATION INTO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181363 ↗
• InjuryJun 22, 2023Difficult to Insert; Wrong Label; Difficult to Insert; Wrong Label

  IT WAS REPORTED THAT A PRIMARY, TOTAL RIGHT HIP REPLACEMENT WAS PERFORMED USING THE CORAIL AND PINNACLE PRODUCTS. IN THIS CASE, THE SIZE OF ACETABULAR LINER CHOSEN WAS A LIPPED 32MM ID 52MM OD LINER. THE IMPLANTS WERE COLLECTED BY A THEATRE SUPPORT WORKER FROM A STOREROOM WHERE ALL IMPLANTS ARE KEPT. THE LABEL ON THE BOX, AS WELL AS THE STICKERS FROM THE BOX BOTH HAD THE FOLLOWING DESCRIPTION: PINNACLE ALTRX POLYETHYLNE, ACETABULAR LINER, LIPPED 32MM ID 52MM OD, REF: 1221-32-252, LOT:M2706Y. THE SIZE OF THE LINER WAS CONFIRMED BY SURGEON PRIOR TO OPENING OF ALL IMPLANTS. THE LINER WAS OPENED, PLACED IN THE ACETABULAR CUP, AND THE SURGERY PROCEEDED. THE FEMORAL HEAD USED WAS A BIOLOX DELTA CERAMIC FEMORAL HEAD +1 32MM DIA 12/14 TAPER, WHICH IS SUPPOSED TO CORRESPOND WITH THE ACETABULAR LINER. THE FEMORAL HEAD WAS INSERTED INTO THE LINER. NO DISLOCATION OCCURRED. FOLLOWING THE PROCEDURE, POST-OPERATIVE X-RAYS WERE TAKEN. THE X-RAYS DISPLAYED THAT THE FEMORAL HEAD DID NOT FIT THE ACETABULAR LINER CORRECTLY AND DID NOT CORRESPOND WITH THE ACETABULAR LINER. AS A RESULT, A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023 AT THE HOSPITAL. THE ACETABULAR LINER REMAINED IN THE PATIENT, AND

  Patient problems: Insufficient Information

  MAUDE report 17181063 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1. PLEASE PROVIDE PART AND LOT OF THE LINER. 122132252 LOT J8846U ALTRX LIPPED 32X52 AND 136532710 LOT 9191953 DLT TS CERAMIC HEAD. 2. AFFECTED SIDE INVOLVED. RIGHT. 3. PLEASE CONFIRM THE YEAR OF THE PREVIOUS REVISION. WAS IT (B)(6) 2021? YES IT WAS (B)(6) 2021 (B)(6) 2021). 4. DATE OF REVISION? (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 12569503 ↗
• InjuryJun 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 12009868 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND REVIEWED: THE OPERATIVE NOTE PROVIDED CONFIRMS THE PATIENT WAS REVISED FOR INSTABILITY AND CHRONIC SUBLUXATIONS. SHE TOLERATED THE PROCEDURE WELL.

  Patient problems: Joint Laxity

  MAUDE report 11807228 ↗
• InjuryMar 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9884862 ↗
• InjuryMar 6, 2020Naturally Worn; Naturally Worn

  REVISION FOR HEAD AND LINER. IT WAS THOUGHT THE LINER WAS CRACKED. LINER WAS NOT CRACKED BUT DEFORMED AT LIP AREA. CERAMIC HEAD WAS MARKED AS IF RUBBED AGAINST CUP. LINER WAS INTACT AND LOCKED. DR REMOVED LINER AND INSPECTED CUP. IMPLANTED NEW LINER AND REPLACED HEAD. DR SAID THE LINER WAS WORN.

  Patient problems: No Code Available

  MAUDE report 9799866 ↗
• InjuryJul 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION, COMPONENT FRACTURE AND DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2007 (STEM, CUP AND HOLE ELIMINATOR). DOI: (B)(6) 2010 (HEAD AND LINER). DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 8771327 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, STICKER SHEETS AND IMPLANT RECORDS RECEIVED. PPF ALLEGES FRACTURE (BONE) AND INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8324982 ↗
• InjuryAug 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISE TO ADDRESS INFECTION. DOI - (B)(4) 2018 ;DOR: (B)(4) 2018; UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7754093 ↗
• InjuryJul 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS WASHOUT DUE TO INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018 UNKNOWN HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7676926 ↗