PINNACLE ALTRX 1221-36-452Recalls & reported problems

Summary

The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 10603295016489), received between Dec 24, 2014 and Sep 21, 2026 — classified as 272 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (126 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 25 most recent of 279 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50848109 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that infected wash out and head/liner exchange.Affected Side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50459427 ↗
• InjuryJun 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S ABDUCTOR TENDON WAS COMPROMISED, SHE HAD DISLOCATED RECENTLY. LINER AND HEAD WERE REPLACED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 25563191 ↗
• InjuryMay 12, 2026Device Dislodged or Dislocated

  IT REPORTED THAT THE PATIENT DISLOCATED. THERE WAS NO ADDITIONAL INFO AND NO DELAY WITH NO NOTHING WRONG WITH THE PRODUCTS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25148489 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY WANTED LIPPED LINER +4 10 DEG AND A LONGER PLUS 12 HEAD. DOI: UNKNOWN . DOR: (B)(6), 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 24968253 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT ACETABULAR COMPONENT WAS REVISED DUE TO GROIN PAIN. NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 24833832 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD A PINNACLE LINER THAT HAD ACCELERATED WEAR AND/OR DISENGAGEMENT OF THE LOCKING MECHANISM. THIS LED TO AN ECCENTRIC HEAD POSITION IN THE SHELL. DOCTOR DECIDED TO REMOVE EXISTING PINNACLE SHELL AND LINER AND REPOSITION A NEW CUP. IT WAS STATED THAT PINNACLE LINER WAS LOOSE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24799733 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED TO ER WITH POSSIBLE INFECTION. DOI: (B)(6) 2026. DOR:(B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24792470 ↗
• InjuryMar 16, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PINNACLE LINER FRACTURED IN THE PATIENT. CUP AND HEAD WERE ALSO REMOVED AND REPLACED WITH EMPHASYS CUP AND LINER AND TS CERAMIC HEAD. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24604387 ↗
• InjuryMar 10, 2026Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24558964 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL ATHA. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24524416 ↗
• InjuryFeb 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. NO PREVIOUS HIP REVISION OTHER THAN CLOSED REDUCTION. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24317363 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY CONCERNS OF THE REVISION SURGEON. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24221691 ↗
• MalfunctionJan 21, 2026Difficult to Insert

  IT WAS REPORTED THAT LINER WAS IMPACTED THEN DISLODGED DURING TRIALING. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133280 ↗
• InjuryJan 2, 2026Device Dislodged or Dislocated

  PATENT REVISED DUE TO DISLOCATION. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 23943948 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY HIP DONE IN NOVEMBER. SHE WAS BROUGHT BACK FOR A LINER/HEAD SWAP DUE TO POSSIBLE INFECTION. THE PINNACLE LINER AND 36MM CERAMIC HEAD WERE REMOVED AND REPLACED WITH A NEW LINER AND A REVISION CERAMIC HEAD. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23877185 ↗
• InjuryDec 2, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED LEGAL RECORDS WERE RECEIVED. THERE IS GAS AND SOFT TISSUE SWELLING SURROUNDING THE LEFT PROXIMAL FEMUR COMPATIBLE WITH POSTOPERATIVE CHANGES. LOOSENING OF FEMORAL COMPONENT OF PROSTHETIC LEFT HIP, SYNOVIAL FLUID FROM HIP JOINT, LEFT ARTHRITISM, PROGRESSIVE HIP PAIN AND DISABILITY. 10 ML OF BLACK STAINED FLUID, ACUTE METAL WEAR PROCESS, POLYETHYLENE LINER WAS WORN THROUGH SUPERIORLY AND BROKEN IN THE SUPERIOR RIM. THE CERAMIC BALL WAS NOTED TO HAVE BLACK STAINING ON THE SUPERIOR SURFACE, WEAR OF ARTICULAR BEARING SURFACE OF INTERNAL PROSTHETIC LEFT HIP JOINT, INITIAL ENCOUNTER (CMS/HCC). HAD SEVERE BACK PAIN/MUSCLE SPASMS. COBALT LEVEL OF 77.1 AND A CHROMIUM LEVEL OF 40.1. DURING THE PROCEDURE, APPROXIMATELY 9 ML OF YELLOWISH FLUID WERE REMOVED. MODERATE AMOUNT OF SCAR TISSUE WHICH WAS STAINED BLACK CONSISTENT WITH A METAL STAINING. SCAR TISSUE WAS EXCISED AROUND THE TRUNNION AND THE ACETABULUM CIRCUMFERENTIALLY. LEFT HIP SORENESS, WEAKNESS, AND DECREASED RECALL OF POSTERIOR. FIBROSIS, FOCAL INFARCTION AND HISTIOCYTIC REACTION SPECIMEN SUBMITTED AS SYNOVIAL SCAR TISSUE CONSISTS OF AN IRREGULAR RUBBERY SEGMENT OF TAN GRAY-RED SOFT TISSUE RECEIVED IN FORMALIN MEASURING

  Patient problems: Adhesion(s); Discomfort; Fatigue; Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 23692798 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. DOI: ON (B)(6) 2020, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23468383 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO I&D OF HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23412233 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FIGHTING INFECTION, THE PATIENT HAD AN I&D POLY SWAP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23337555 ↗
• InjurySep 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD CONSISTENT DISLOCATION. THE PATIENT UNDERWENT REMOVAL OF LINER, BIOLOX HEAD, ACTIS SIZE 3 STEMS. THE SURGEON REPLACED IT WITH A COMPETITOR STEM. THERE WAS NO DELAY IN CASE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 23037081 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY DUE TO FRACTURE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23019994 ↗
• InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A LEFT PRIMARY HIP WAS DONE ON (B)(6) 2025. THE PATIENT WAS TAKEN FOR RECOVERY. PATIENT MADE A JERKING MOTION AND HAD SOME DISCOMFORT. THE STAFF DETERMINED THAT PATIENT HAD DISLOCATED. THE SURGEON, TOOK THE PATIENT BACK TO THE OR AROUND 2PM ON (B)(6) 2025. THE CUP, LINER, & SCREWS WERE REMOVED. THE SURGEON REPOSITIONED A NEW CUP, ADDED 2 SCREWS, AND A +4/10* LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Joint Dislocation

  MAUDE report 23006687 ↗
• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22664528 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON WAS UNABLE TO REDUCE AND PERFORMED CLOSED CONVERSION TO CONSTRAINED LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22644752 ↗