PINNACLE ALTRX 1221-40-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295016588), received between Apr 10, 2018 and Nov 6, 2025 — classified as 35 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A WASHOUT/POLY EXCHANGED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23490794 ↗
• InjuryJul 31, 2025Fracture; Fracture

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(4) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: THE PINNACLE POLY LINER WAS REVISED DUE TO FRACTURE OF THE LINER. THE LINER SHOWED SEVERE YELLOWING.

  Patient problems: Insufficient Information

  MAUDE report 22675420 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22481159 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION. AT REMOVAL THE ACETABULAR LINER SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 21981408 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS INFECTED SO THE DOCTOR DECIDED TO DO A HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21620300 ↗
• InjuryMay 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UPDATE AD 24 APR 2024: LEGAL DOCUMENTS NOTE THE PATIENT DISLOCATED ON (B)(6) 2019, (B)(6) 2019. THERE WERE NO MEDICAL RECORDS PROVIDED THAT DISCUSSED DISLOCATION. DOI: (B)(6) 2019. DOE: (B)(6) 2019 ( PINNACLE HEAD & LINER ). AFFECTED SIDE: RIGHT HIP. THIS PC IS RELATED TO (B)(4) & (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 19331142 ↗
• InjuryDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018 CLOSED DISLOCATION OF RIGHT HIP, PATIENT REPORTED HAVING RIGHT HIP PAIN. PATIENT WAS NOTED TO HAVE HAD HIP SURGERY 2 WEEKS AGO FOR REMOVAL OF PSEUDOTUMOR HIP REPLACEMENT. ON (B)(6) 2021, MEDICAL RECORDS NOTE THE PATIENT HAS RIGHT HIP PAIN. ON (B)(6) 2023, THE PATIENT HAD A RIGHT SACROILIAC JOINT INJECTION TO ADDRESS PAIN IN RIGHT HIP AND SACROILIITIS.

  Patient problems: Hypersensitivity/Allergic reaction; Joint Dislocation; Pain

  MAUDE report 18325652 ↗
• InjuryNov 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD PRIOR TOTAL HIP ARTHROPLASTY AND WAS REVISED PREVIOUSLY ON (B)(6) 23. WE REMOVED A 122140160 AND A (B)(6) AND PLACED A 36 X 60 CONSTRAINED LINER AND A 36+5 METAL HEAD BECAUSE PATIENT HAS HAD A PREVIOUS DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18056853 ↗
• InjuryOct 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT NO THE SURGERY TIME WAS EXTENDED.

  Patient problems: Joint Dislocation

  MAUDE report 17966227 ↗
• InjuryOct 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17958441 ↗
• InjuryJul 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT'S HIP REVISION DUE TO HIP DISLOCATION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17324764 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT HIP. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16537460 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, PHYSICAL THERAPY NOTES STATING THE LEFT HIP DEMONSTRATES AN EFFUSION AND THE PATIENT HAS RECENTLY FALLEN. PHYSICAL THERAPY NOTES ON (B)(6) 2021 STATE THE LEFT HIP IS VERY SWOLLEN, RED, AND HARD. THE PATIENT ALSO STATES HE MAY HAVE HAD A LOW GRADE FEVER. THE TREATMENT WAS NOT COMPLETED DUE TO CONCERNS OVER INFECTION. NOTES DETAIL A PHYSICAL THERAPY EVALUATION PERFORMED ON (B)(6) 2021. THE NOTES STATE THE LEFT HIP IS BRUISED WITH A SIGNIFICANT EFFUSION. THIS PC WAS CREATED TO CAPTURE THE HARM REPORTED POST LEFT HIP REVISION ON (B)(6) 2021.

  Patient problems: Ecchymosis; Erythema; Fall; Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 16111782 ↗
• InjuryJun 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR EARLY SUSTAINED DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: 12FEB2022; (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation; Low Blood Pressure/ Hypotension

  MAUDE report 14701181 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT INFECTION OF THE HIP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2017. DATE OF REVISION: (B)(6) 2017. RIGHT HIP TREATMENT: REVISION OF HEAD AND LINER AND I&D.

  Patient problems: Unspecified Infection

  MAUDE report 14625800 ↗
• MalfunctionSep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY WAS A COMPETITOR CONSTRUCT DONE ~15 YEARS AGO. ON (B)(6) 2021, SURGEON REVISED THE ACETABULAR CUP AND PLACED IN DEPUY PRODUCTS. PATIENT FELL IN (B)(6)... NO ISSUES. ON (B)(6) SHE DISLOCATED ON THE 11, 13, & 15. CLOSED REDUCTIONS WERE PERFORMED. ON THE 15TH, THE SURGEON SCHEDULED TODAY'S REVISION. THERE APPEARED TO BE NO CAUSE OR EXPLANATION TO THE DISLOCATION. SURGEON MANIPULATED THE CONSTRUCT PRIOR TO REVISING COMPONENTS AND THE HIP PERFORMED WELL, NO DISLOCATION. SURGEON DECIDED TO REMOVE THE LINER IMPLANTED IN (B)(6) WITH A CONSTRAINED LINER TO PREVENT ANY FURTHER DISLOCATION. DOI: 2006, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 12445852 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS BEING REVISED DUE TO PAIN/ DISCOMFORT. DR. STATED SHE HAD MULTIPLE SURGERIES PRIOR. DOI: (B)(6) 2013. DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Discomfort; Pain

  MAUDE report 12345058 ↗
• InjuryFeb 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE AND DISLOCATED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11331694 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CONTINUING CARE FOR THE INFECTED HIP. THE SURGEON EXCHANGED MODULAR IMPLANTS WHILE EXTRACTING ANTIBIOTIC BEADS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10683117 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A CONSTRAINED POLY FOR ADDED STABILITY. DOI: 5 DEC 2019, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 10329354 ↗
• InjuryJul 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CUP WAS REVISED DUE TO DISLOCATION, REVISED TO COMPETITOR PRODUCT. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10303099 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON CALLED ON (B)(6) 2020 AND SAID THAT THE PATIENT THAT HE DID A LT THA ON (B)(6) 2020 BECAME INFECTED AND THAT HE WANTED TO DO AN I&D AND HEAD/LINER EXCHANGE. THE SURGEON REMOVED BOTH THE LINER AND METAL HEAD, PERFORMED I&D. HE IMPLANTED THE SAME SIZE IMPLANTS AND ALSO PUT IN STIMULAN BEAD FOR THIS PATIENT. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9983259 ↗
• InjuryFeb 17, 2020Fracture; Fracture

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES DEVICE WAS DEFECTIVE RESULTING TO FRACTURED CUP. DOI: (B)(6) 2016; DOR: UNKNOWN; HIP KNOWN.

  Patient problems: No Code Available

  MAUDE report 9717094 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION: I&D POSSIBLE INFECTION. CEMENT USED WAS NOT DEPUY'S. THE HEAD AND LINER WERE REMOVED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9707173 ↗
• InjuryFeb 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED RECURRENT DISLOCATION. OPERATIVE NOTES INDICATED CLEAR JOINT FLUID AND NO SIGN OF INFECTION WAS NOTED. DOI: (B)(6) 2012; DOR: (B)(6) 2014; RIGHT HIP 3RD REVISION. PLEASE SEE (B)(4) RIGHT HIP 1ST REVISION (B)(4) RIGHT HIP 2ND REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9660808 ↗