PINNACLE ALTRX 1221-36-458Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10603295016519), received between Aug 25, 2014 and Sep 17, 2026 — classified as 82 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (32 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 86 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Device Dislodged or Dislocated

  It was reported that patient dislocated hip. Surgeon placed a constrained liner. There were no delays or complaints. No harm to patient.Affected side-Right hip.

  Patient problems: Joint Dislocation

  MAUDE report 50800526 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50724323 ↗
• InjuryAug 7, 2026Naturally Worn; Appropriate Device Problem Term/Code Not Available

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to fractured femoral stem and pain. The non-articular surface of the polyethylene acetabular liner shows minor yellowing and 3 screw hole defects.

  Patient problems: Pain

  MAUDE report 50178628 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED HE FELT UNSTABLE. THERE WAS NO HARM TO PATIENT. NO DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25735764 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED, I & D WASHOUT WAS PERFORMED WITH A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25205948 ↗
• InjuryJan 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED ABOUT 12 TIMES IN THE LAST 2 YEARS. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24179613 ↗
• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY/DISLOCATION. NO OTHER INFORMATION IS KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 23838194 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT TOTAL HIP THAT WAS INFECTED. THE SURGEON DID A WASHOUT WITH HEAD AND LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21632302 ↗
• InjuryJan 27, 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 UNSTABLE RIGHT TOTAL HIP. THE SURGEON REVISED THE LINER TO A FACE CHANGING LINER AND WENT TO A LARGER DIAMETER HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21243146 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SUBCUTANEOUS INFECTION. HEAD, LINER, STEM WERE REMOVED. THERE WAS NO DELAY IN CASE. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21091491 ↗
• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HIP SUBLUXATION DUE TO HETERETOPIC BONE ON RIM OF THE SHELL. DOI: (B)(6) 2024 , DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT HIP.

  Patient problems: Extraskeletal ossification; Joint Dislocation; Joint Laxity

  MAUDE report 20726291 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL CORAIL, SUSPECTED PADDING. REMOVAL REQUIRED EXTENSIVE OSTEOTOMY AFTER A LONG ATTEMPT TO REMOVE. SUMMIT WAS CONSIDERED BUT THE LENGTH OF OSTEOTOMY REQUIRED A MODULAR RECLAIM. PATIENT WAS REAMED AND X-RAYS WERE BALANCED AND SOLID. PATIENT WAS REDUCED WELL & STABLE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19574589 ↗
• MalfunctionApr 25, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS MULTIPLE ATTEMPTS TO SEAT/TAPER THE LINER WAS UNSUCCESSFUL. SURGEON IMPLANTED SAME LINER AFTER UNSUCCESSFUL ATTEMPTS WITH NO PROBLEM. DOE: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19186411 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: - THE CUP WAS NOT REVISED AND NO SURGICAL DELAY.

  Patient problems: Extraskeletal ossification

  MAUDE report 19041881 ↗
• InjuryDec 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION AND THE SURGEON CHANGED OUT THE HEAD AND LINER TO DUAL MOBILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18311004 ↗
• InjuryNov 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WAS SURGERY TIME EXTENDED DUE TO A DEPUY SYNTHES PRODUCT? IF YES, WHAT WAS THE DURATION OF THE DELAY? SURGERY WAS NOT DELAYED DUE TO DEPUY PRODUCTS. B. PLEASE PROVIDE THE REASON WHY THE CUP AND SCREW WERE REVISED. WAS THERE AN INDICATION THAT THE CUP AND SCREW WERE MALPOSITIONED OR MIGRATION THAT CONTRIBUTED TO DISLOCATION? THE CUP HAD MORE ANTERVERSION THAN USUAL. THE DEPUY IMPLANTS HAD NOT MIGRATED. THE CUP WAS SOLID. I DUAL MOBILITY IMPLANT WAS EXCHANGED AND PATIENT WAS STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 18096972 ↗
• InjuryNov 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONICALLY DISLOCATING, A 40MM LIPPED LINER WAS PLACED WITH A 40MM HEAD. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 18085158 ↗
• InjuryOct 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17950055 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD AND LINER WAS EXCHANGED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17556425 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE'S NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17488027 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FAILED LEFT HIP. REVISION NECESSARY. INFECTION PLAUSIBLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17458308 ↗
• InjuryJun 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UPDATED EVENT DESCRIPTION: AFTER REVIEW OF THE MEDICAL RECORDS, CLINICAL VISIT REPORTED CONSISTENT MOM DISEASE , PAIN AND LIMITED ADL, DIFFICULTY WALKING AND MUSCLE WEAKNESS AFTER FIRST REVISION OF THE LEFT HIP. ON (B)(6) 2020 COBALT 6.7 MCG/L CHROMIUM 34.6 MCG/L ON (B)(6) 2021 LEFT HIP MRI NOTED A LARGE FLUID COLLECTION ALONG WITH TEARS OF THE LEFT GLUTEUS MEDIUS AND MINIMUS TENDON INSERTIONS. ON (B)(6) 2021 LAB RESULTS: CHROMIUM 24.3 UG/L. ON (B)(6) 2022 RADIOGRAPHS OF THE LEFT HIP ARE REPORTED TO SHOW THE ACETABULAR COMPONENT IS A LITTLE VERTICAL IN ORIENTATION. THE PATIENT NOTED THAT THEIR HIP FEELS UNSTABLE. IT WAS NOTED THAT ON (B)(6) 2022 THE PATIENT¿S HIP DISLOCATED AND THEY NEEDED A CLOSED REDUCTION. ON (B)(6) 2022 LAB VALUES NOTED COBALT WAS 3.1 AND CHROMIUM PLASMA WAS 33.5 WITH NO UNIT OF MEASUREMENT PROVIDED. ON (B)(6) 2022 THE PATIENT LEFT TOTAL HIP REVISION TO ADDRESS INSTABILITY, PAIN, AND ABDUCTOR WEAKNESS LEFT HIP. PRIOR TO SURGERY, THE PATIENT REPORTED THAT THEY FEEL POPPING AND HAD DISLOCATED. DURING THIS PROCEDURE, THE SURGEON OBSERVED LARGE JOINT EFFUSION, METAL DEBRIS AS EVIDENCED BY BLACK SYNOVIAL TISSUE. THE PATIENT¿S ABDUCTOR MUSCLES WERE NOTED TO SIGNIFICA

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Joint Dislocation; Joint Laxity; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17208272 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THE HEAD WAS REVISED FROM 36+5 TO 36+15.5. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16751727 ↗
• InjuryApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 16723243 ↗
• InjuryApr 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION REOCCURRENCE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2013, DATE OF EVENT: ON (B)(6) 2023, (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 16662804 ↗