PINNACLE ALTRX 1221-36-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10603295016366), received between Aug 30, 2017 and Sep 23, 2026 — classified as 100 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (51 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 103 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the I&D poly swap & head exchange. No issues or problems or delays during this case.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Insufficient Information

  MAUDE report 50872177 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had prostalac spacer for infection, right hip. Removal of all implants from original surgery date of (b)(6) 2026. Affected side- Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50497445 ↗
• InjuryApr 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE REVISIONS, AFTER A REVISION ON (B)(6) 2026. THE PATIENT DISLOCATED. THE CUP WAS REVISED AND A DUAL MOBILITY WAS IMPLANTED WITHOUT INCIDENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24819014 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS WASHOUT FOR INFECTION. EXPLANTED THE ALTRX 60X36 LINER, THE HOLE ELIMINATOR, AND 36 BIOLOX DELTA HEAD. WASHOUT WAS CONDUCTED AND NEW HOLE ELIMINATOR, 60 ALTRX LINER AND A 36 + 8.5 COBALT CHROME HEAD WAS IMPLANTED. NO DELAY IN SURGERY. NO INJURY TO PATIENT. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24661547 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AN INFECTED HIP. ALL PRODUCTS WERE REMOVED FOR A SPACER. NO HARM WAS DONE ALL PIECE WERE REMOVED. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24532086 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC REMOVAL OF IMPLANTS. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Sepsis

  MAUDE report 23634264 ↗
• InjuryOct 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PINNACLE ALTRX LINER 36 X 60 GOT DETACHED FROM THE PINNACLE CUP. THE SURGEON PLANS TO REVISE THIS AND NEED TO GET A CUSTOM DUAL MOBILITY CUP.

  Patient problems: Insufficient Information

  MAUDE report 23349582 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO CLINIC COMPLAINING OF A NEW PAIN IN LEFT HIP THAT WAS PRESENTED FOLLOWING A LONG ROAD TRIP. THE HIP WAS ASPIRATED AND THE CULTURE RETURNED POSITIVE. THE SURGEON FELT THAT I&D WITH HEAD AND POLY EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEADS WOULD BE BEST FOR THE PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23316719 ↗
• InjurySep 5, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT 36X60 +4N LINER SEEMED TO HAVE SPUN OUT AND DAMAGED. HALFWAY STUCK IN CUP AND HALF OUT. METALOSIS PRESENT DUE TO HEAD RUBBING ON CUP. CUP WAS NOT REVISED. A DUAL MOBILITY LINER WAS REPLACED AS WELL AS A NEW HEAD. THERE WAS A RECLAIM MODULAR STEM IN SO WE REMOVED THE PROXIMAL BODY, AND PUT A NEW ONE IN SO THE TRUNNION WAS BRAND NEW. ORIGINAL SURGERY WAS (B)(6) 2020 W DR. RUSSO. ON (B)(6) 2020 THE STEM WAS REVISED TO A RECLAIM MODULAR AS THE ACTIS STEM WAS LOOSE. THEN MOST RECENTLY ON (B)(6) 2025 THERE WAS A REVISION BECAUSE THE LINER WAS DISSOCIATED. WE REPLACED THE PROXIMAL BODY ON THE RECLAIM AND CONVERTED ACETABULAR SIDE TO DUAL MOBILITY. LINER WAS DISSOCIATED. THE POLY IMPLANT WAS WORN AND IT LOOKED LIKE IT WAS WORN BC THE HEAD WAS RUBBING AGAINST THE SIDE OF THE DISSOCIATED LINER. THERE WERE NO ISSUES W TRUNNION OR PROXIMAL BODY. DOI: (B)(6) 2020 FIRST DOR: (B)(6) 2020. SECOND DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP. (B)(4) IS RELATED TO (B)(4) WAS CREATED FOR FIRST REVISION SURGERY. (B)(4) WAS CREATED FOR SECOND REVISION SURGERY.

  Patient problems: Foreign Body Reaction

  MAUDE report 22976065 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO INFECTION. ALONG WITH THAT TWO INSTRUMENTS WERE REPORTED FOR UNKNOWN ALLEGATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22848460 ↗
• InjuryJul 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PINNACLE LINER DISSOCIATION. THERE WAS A LINER LOOSENING AT NON-CEMENTED INTERFACE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22508061 ↗
• InjuryJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP ON (B)(6) 2025. PATIENT WAS UNSTABLE AND DISLOCATED THE MORNING OF (B)(6) 2025. THE SURGEON DECIDED TO TAKE PATIENT BACK TO DO A HEAD AND LINER EXCHANGE FOR MORE STABILITY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22440325 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO INFECTED HIP. THIS IS STAGE 1 OF 2 STAGE REVISION. NO DELAY IN CASE. THE LOT NUMBERS ARE NOT KNOWN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22338659 ↗
• InjuryMay 14, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO REPEATED DISLOCATION. TWO CONSTRAINED LINERS BROKE TRYING TO REDUCE HIP. THERE WAS SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22018593 ↗
• InjuryMar 24, 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 PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21676139 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS HIGH CELL COUNT. SURGEON TOOK CUP, LINER, AND HEAD OUT TO DO A WASH. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21571313 ↗
• InjuryMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ACETABULAR LINER WAS DISLODGED AND THEREFORE NEEDED TO BE REMOVED. THE CERAMIC HEAD AND TWO CANCELLOUS BONE SCREWS WERE ALSO REMOVED. A DM LINER AND HEAD CONSTRUCT WERE THEN IMPLANTED. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 21547196 ↗
• MalfunctionFeb 4, 2025Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE SURGERY WAS NOT DELAYED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305441 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH A POST OPERATIVE INFECTION. A ONE STAGE REVISION WAS PERFORMED, WHERE JUST THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21199070 ↗
• InjuryJan 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 PROGRESSIVE HIP PAIN AND WOUND DRAINAGE 6 WEEKS POST OP TOTAL HIP. BACTERIA NOT IDENTIFIED YET. NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Pain

  MAUDE report 21162068 ↗
• InjuryOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD FAILURE OF HIS POLYETHYLENE LINER. THERE HAS BEEN DISSOCIATION OF THE CUP FROM THE LINER. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT AND EXPLANT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20374446 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED FOR THE LEFT HIP ON (B)(6) 2024 DUE TO PAIN. DATE OF IMPLANT IS UNKNOWN

  Patient problems: Pain

  MAUDE report 20370170 ↗
• MalfunctionJun 21, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER WOULD NOT SEAT FLUSH. LINED UP BUT TABS DID NOT GO ALL THE WAY DOWN. HAD TO EXTRACT. DOE: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19590203 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. HEAD AND LINER EXCHANGED DURING WASH OUT. DOI- (B)(6) 2024; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19557391 ↗
• InjuryApr 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PINNACLE LINER DISASSOCIATED FROM PINNACLE SHELL. DOI: UNKNOWN. DOE: (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19099615 ↗