PINNACLE ALTRX 1221-28-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295015932), received between Sep 1, 2017 and Sep 15, 2025 — classified as 34 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (21 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 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 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 INSTABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23052985 ↗
• InjuryJun 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATION. THERE WAS NO HARM TO PATIENT AND NO DELAYS. THERE WAS NO BROKEN INSTRUMENT. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22133872 ↗
• InjuryMay 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 INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22089478 ↗
• InjuryJul 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD BEEN DISLOCATING AND HAD A MINOR INFECTION SINCE DISCHARGE FROM THE ORIGINAL IMPLANT ON MAY 1. THE PATIENT HAD A DEEP INFERIOR FEMORAL FRACTURE ABOUT TWO YEARS PRIOR AND HAD BEEN LIVING WITHOUT A FUNCTIONING JOINT UNTIL (B)(6) 2024. THE PATIENT WAS 58MM SHORT AT THE INITIAL IMPLANT AND SOFT TISSUES WERE EXTREMELY TIGHT, POSSIBLY AIDING IN DISLOCATION. DR. ACCESSED THAT THE STEM WAS IN GOOD VERSION, WELL-FIXED, AND AT GOOD LEG LENGTH. DR. ACCESSED THAT THE CUP WAS IN GOOD INCLINATION AND VERSION. THE NEUTRAL LINER WAS EXCHANGED FOR A +4 10 DEG LINER AND THE +1.5 HEAD WAS CHANGED FOR A + 5 TS HEAD DUE TO SOFT TISSUE LACTATION OVER THE LAST MONTH. THERE WERE NO COMPLAINTS FROM THE SURGEON OR STAFF AND NO DELAY IN OR TIME. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19648991 ↗
• InjuryMay 9, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THERE WAS A POLY AND LINER EXCHANGE DUE TO X RAYS SHOWING THE FEMORAL HEAD WAS ARTICULATING SUPERIOR. AFTER EXPOSING THE ACETABULUM IT WAS EVIDENT THERE WAS SOME UNUSUAL WEAR PATTERNS ON THE POLY. AFTER FURTHER INVESTIGATION IT SEEMS THAT THE LINER WAS NOT PROPERLY INSERTED IN THE PINNACLE CUP. NO ISSUES WERE FOUND WITH THE LOCKING MECHANISM OF THE CUP. NEW LINER WAS INSERTED. FEMORAL HEAD SHOWS AUDIBLE WEAR FROM RUBBING ON THE ACETABULAR RIM. SURGICAL TIME WAS NOT EXTENDED. PRODUCTS WILL BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19278930 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: PAIN, OTHER.

  Patient problems: Pain

  MAUDE report 19176654 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19044310 ↗
• InjuryMar 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE POLYETHYLENE LINER WAS DISLODGED FROM THE CUP AND NEEDED TO BE REMOVED AND REPLACED WITH A NEW ONE ALONG WITH THE FEMORAL HEAD. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18989130 ↗
• InjuryMar 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LINER LOCKING MECHANISM FAILED. SURGICAL DELAY UNKNOWN. DOE: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18967887 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A HIP DISLOCATION THEREFORE WENT TO DUAL MOBILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(3) 2023. DOR: (B)(3) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 18363354 ↗
• MalfunctionNov 29, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER DISASSOCIATED DURING REDUCTION. SURGICAL DELAY 15 MINUTES. DOE: (B)(6). 2023 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 18226384 ↗
• MalfunctionNov 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISSOCIATION OF LINER DURING FINAL REDUCTION OF HIP. THE SURGEON REMOVED THE LINER AND IMPLANTED A NEW ONE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18103181 ↗
• InjuryJun 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR DISLOCATION. SURGEON EXPLANTED THE CUP, LINER, HEAD AND SCREW. REAMING WAS CONDUCTED TO INCREASE THE SIZE OF THE CUP. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17200022 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTION SURGEON REPLACED POLY LINER AND HEAD. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16477831 ↗
• InjuryFeb 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LINER BECAME DISASSOCIATED FROM THE CUP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16381264 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR HEAD AND LINER EXCHANGE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16157374 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED HIP. SURGEON REMOVED ALL THE IMPLANTS, REAMED THE CANALS, IRRIGATED AND PLACED ANTIBIOTIC BEADS BEFORE RE-IMPLANTING. SURGEON USED A CORAIL REV STEM, CERAMIC HEAD AND ZIMMER CUP. NO FURTHER PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15799014 ↗
• InjuryOct 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO THE LINER DISASSOCIATED FROM CUP. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 15588356 ↗
• InjurySep 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SECOND REVISION COMPLETED DUE TO DISLOCATION. DOI- (B)(6) 2022; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15335056 ↗
• InjuryJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14622403 ↗
• InjuryNov 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A: FOR REPORTS OF DISASSOCIATION WE ARE REQUIRED TO ENTER THE ACETABULAR CUP EVEN IF IT WAS NOR REVISED . CAN YOU PLEASE PROVIDE THE ACETABULAR CUP PRODUCT / LOT INFORMATION? ALTRX PE-INLAY 28 X46 MM, HZ5395, 01106032950159321723 AND PINNACLE BANTAM CUP 46 MM, UDI (B)(4). B: WAS THERE A SURGICAL DELAY DURING THE RE VISION SURGERY? IF YES, PLEASE INDICATE NUMBER OF MINUTES DELAYED. I DON'T UNDERSTAND THIS QUESTION, I DIDN'T PERSONALLY DO THE REVISION. IT WAS DONE BY PROF. DORA. THE CASE TOOK ABOUT 1 1 /2 HOURS SO I GUESS WENT NORMAL. C. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? THE PRIMARY THA WAS DONE ON (B)(6) 2019 AND THE PATIENT DID QUITE WELL AND WAS VERY HAPPY FOR 2 YEARS UNTIL THE DISLOCATION HAPPENED (SPIN OUT) . D: WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT HIP. E: PLEASE PROVIDE PATIENT INITIALS. (B)(6) F. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS THAT LED TO THE REVISION SURGERY? IF YES, PLEASE PROVIDE DETAILS. YES WHEN SHE EXPERIENCED THIS SPIN OUT SHE WAS UNABLE TO WALK UNTIL THAT DAY SHE WAS COMPLETELY SYMPTOM FREE. G: PLEASE PROVIDE ALL X-RAYS RELEVANT TO THE REPORTED EVENT FOR EXAMPLE - PRE-OPERATIVE, POST PRIMARY

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12788449 ↗
• InjuryOct 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED. DOI: (B)(6) 2021, DOR: (B)(6)2021, RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12615833 ↗
• InjurySep 17, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A SQUEAKING HIP AND UNDERWENT REVISION SURGERY. THE POLY WAS FOUND TO BE WORN, AND WAS DISSOCIATED FROM THE CUP. THE SURGEON SAYS IT ¿SPUN OUT¿. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12487411 ↗
• InjuryDec 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ACETABULAR LINER DISASSOCIATED FROM SHELL. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11078341 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10184571 ↗