PINNACLE ALTRX 1221-32-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 386 adverse event reports that list this exact device (DI 10603295016106), received between Jul 21, 2017 and Sep 23, 2026 — classified as 379 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (207 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 386 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 patient is unstable. The cup and liner were taken out and their position was changed during a revision procedure.DOI: (b)(6) 2010.DOR: (b)(6)2026.Affected side: Left hip.

  Patient problems: Joint Laxity

  MAUDE report 50873110 ↗
• InjurySep 16, 2026Fracture; Device Dislodged or Dislocated

  Patient problems: Insufficient Information

  MAUDE report 50794675 ↗
• InjurySep 8, 2026Device Dislodged or Dislocated

  It was reported that patient had hip replaced sometime ago, date is unknown. Doctor reported patient had severe dementia and experienced several dislocations over the last several months. Doctor opted for complete revision to provide additional stability.DOI: Unknown.DOR: Unknown.Affected side: Right.

  Patient problems: Joint Dislocation

  MAUDE report 50672535 ↗
• InjuryJul 27, 2026Device Dislodged or Dislocated

  It was reported that patient underwent total hip arthroplasty (THA) on (b)(6) 2024. The then presented to the emergency department on (b)(6)2026, complaining of severe pain in the left hip which had worsened significantly since the previous evening. Weight-bearing on the left leg was barely possible; the patient denied any preceding trauma. The patient had repeatedly noticed a "grinding" or "popping" sensation in the left hip while walking.An earlier consultation on (b)(6) 2026, due to increasing hip discomfort, had revealed no radiological or CT evidence of prosthesis loosening, periprosthetic fracture, or inlay dislocation. At that time, the femoral head appeared properly centered within the acetabular component. Current diagnostic imaging revealed an eccentric position of the prosthetic head within the acetabular component. CT findings raised suspicion of inlay dislocation or a material defect in the hip prosthesis. Additionally, an extensive periprosthetic fluid collection containing air pockets was noted. However, clinical and laboratory findings showed no evidence of an acute infection.Based on these findings, an indication for emergency surgical revision was established. Cup

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 50045233 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 25084851 ↗
• InjuryApr 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISENGAGED LINER. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958150 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A THA IN 2020. THE PATIENT PRESENTED WITH SIGNS OF OSTEOLYSIS AND LYTIC CHANGES BEHIND ACETABULAR CUP. CUP WAS EXPLANTED, PELVIS DEBRIDED AND REVISED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Osteolysis

  MAUDE report 24746109 ↗
• InjuryMar 16, 2026Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE PINNACLE LINER WAS FOUND TO BE DISLOCATED. THE PATIENT REPORTED HEARING A "POP" PRIOR TO PRESENTATION. UPON INSPECTION, THE LINER'S ROTATIONAL TABS WERE NOTED TO BE WORN OFF. THE CERAMIC HEAD EXHIBITED BLACK DEBRIS. DOCTOR DOCUMENTED SIGNS OF OSTEOLYSIS AND MEDIAL CALCAR BONE LOSS. DOCTOR INSPECTED THE LOCKING MECHANISM AND WAS SATISFIED WITH ITS INTEGRITY, PROCEEDING WITH REPLACEMENT OF THE LINER. THE PATIENT REQUESTED TO KEEP THE IMPLANTS REMOVED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Bone Notching; Osteolysis

  MAUDE report 24605388 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR RIGHT HIP INSTABILITY. THERE WAS NO SURGICAL DELAY. ACTIVITY LEVEL WAS YES. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24592755 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NOT STABLE-HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24581548 ↗
• InjuryMar 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POLY LINER DISASSOCIATED FROM THE CUP. CAUSE OF DISASSOCIATION IS UNKNOWN. SURGEON TOOK OUT OLD LINER AND HEAD AND REPLACED WITH A NEW LINER AND HEAD. NO FURTHER ISSUES OR CONCERNS. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24487377 ↗
• InjuryFeb 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED REVISION OCCURRED DUE TO MASSIVE METAL WEAR DURING INLAY DISLOCATION AND FRACTURE FOLLOWING EXTERNAL ENDOPROSTHETIC TREATMENT. NECESSARY REVISION INCLUDING CUP AND HEAD REPLACEMENT, AS WELL AS REMOVAL OF METAL WEAR AND PSEUDOTUMOR. DOI: (B)(6) 2024. DOR: (B)(6) 2026.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24460268 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24221501 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24040354 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: (B)(6) 2025.

  Patient problems: Joint Dislocation

  MAUDE report 24006590 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ITEMS EXPLANTED DUE TO UNSTABLE CUP. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 23996963 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23802884 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD / LINER EXCHANGE WAS WASH OUT.

  Patient problems: Insufficient Information

  MAUDE report 23754351 ↗
• InjuryDec 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LINER POPPED OUT OF THE CUP, DISLOCATING THE HIP. REPLACED LINER AND HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23726825 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERS FROM PAIN/FALL. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Pain

  MAUDE report 23512718 ↗
• InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LINER DISSOCIATED TWICE. IMPLANTS APPEARED TO BE INTACT/UNBROKEN. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23318670 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL HIP SURGERY DONE (B)(6) 2025 AT (B)(6) SURGERY CENTER BY DR. UNFORTUNATELY, THE PATIENTS HIP BECAME INFECTED. DR. OPTED TO DO AN IMMEDIATE EXCHANGE WHERE HE WAS GOING TO TAKE OUT ALL THE IMPLANTS, THOROUGHLY WASHOUT THE HIP, THEN IMPLANT NEW COMPONENTS. THE PATIENT WAS PREPPED WITH A 52MM EMPHASYS CUP, WHICH ALLOWED DR. TO UTILIZE A 40MM LINER FOR ADDED STABILITY. THE FEMORAL CANAL WAS THEN PREPPED FOR A 5HI STEM AND A TRIAL REDUCTION WAS PERFORMED WITH A 40MM +1.5 HEAD. DR. FELT THAT THE 40 +5 WAS BETTER AND IMPLANTED IT. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025, DOE: UNKNOWN, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23069106 ↗
• InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22994672 ↗
• InjuryAug 8, 2025Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT UNDERWENT RIGHT THR EIGHTEEN MONTHS PRIOR. PROCEDURE WAS COMPLETED WITH NO PROBLEMS. THE PATIENT HAD TO BE REVISED DUE TO NINE MONTH HISTORY OF CLUNKING/SUBLUXATION AND SIX DAY HISTORY OF SQUEAKING. X-RAY SHOWED LINER DISSOCIATION. INTRAOPERATIVELY, THE LINER SPUN INFERIORLY WITH HEAD ARTICULATING WITH SHELL.

  Patient problems: Joint Laxity

  MAUDE report 22749287 ↗
• InjuryAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A RTHA. PATIENT DISLOCATED AND NEEDED TO BE REVISED. DOI: (B)(6) 2025. DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 22691709 ↗