PINNACLE ALTRX 1221-36-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 388 adverse event reports that list this exact device (DI 10603295016335), received between Jun 29, 2017 and Sep 17, 2026 — classified as 372 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (123 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 388 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Device Dislodged or Dislocated

  It was reported that chronic dislocation of right total hip. They removed acetabular liner and exchanged with a new constrained liner. The femoral head was also exchanged but it was a competitor's femoral head.Affected side: Right hip.

  Patient problems: Joint Dislocation

  MAUDE report 50800440 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient fell and broke lateral side of the bone. Surgeon removed the Summit stem and implanted a revision stem. Surgeon swapped out the liner and head also.Affected Side: Left Hip.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 50752591 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported I & D of an infected hip. Surgeon chose to replace the head and liner.DOI: Unknown DOR: (b)(6) 2026Affected side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50713618 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to COP unstable, changing head and liner.DOI: (b)(6) 2020.DOR: (b)(6) 2026.Affected side: Left.

  Patient problems: Joint Laxity

  MAUDE report 50128724 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Dr chose to swap out the head and liner for an infected hip. Also removed the screw.Affected Side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50126990 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ASSOCIATED WITH PROSTALAC. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25086571 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LATERAL PAIN. SURGEON OPENED UP JOINT SPACE AND DECIDED TO DO A POLY AND HEAD SWAP TO TIGHTEN THE SOFT TISSUES. SALES RE DON'T KNOW THE LOT NUMBERS. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24999727 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED HIP, SO THE SURGEON DECIDED TO REMOVE THE POLY LINER AND HEAD AND REPLACE WITH NEW IMPLANTS. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24876549 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION HEAD AND LINER WAS EXCHANGED. THERE WAS NO DELAY TO THE CASE AND NO HARM TO THE PATIENT. THERE WAS NO FURTHER INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24789296 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION, WHICH REQUIRED A WASHOUT AND EXCHANGE OF THE HEAD AND LINER. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24706881 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALL RESULTING IN A FEMUR FRACTURE. THE FEMUR SINCE HEALED HOWEVER THE HIP BECAME UNSTABLE AND THEN REQUIRED REVISION. NO INFECTION NOTED. INDEX PROCEDURE CARRIED OUT.

  Patient problems: Fall; Joint Laxity

  MAUDE report 24475257 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHELL/HEAD REVISED DUE TO INSTABILITY/FRACTURE. IT WAS STATED THAT THE SHELL WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24327017 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DUE TO IMPLANT. DOI- UNKNOWN DOR- (B)(6) 2026 AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24240902 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 24212103 ↗
• InjuryJan 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24116694 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24101601 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DEVELOPED HETEROTOPIC BONE AROUND THE JOINT SO THE DOCTOR DID A POLY HEAD EXCHANGE WHILE IN THE JOINT REMOVING THE BONE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching

  MAUDE report 23975019 ↗
• InjuryDec 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS HIP REVISION DUE TO METALLOSIS. METAL LINER AND HEAD WERE REMOVED AND THOROUGH WASHOUT IN PREVIOUS SURGERY. OVER THE LAST FIVE TO SIX MONTHS, PATIENT HAS HAD CHRONIC ISSUES WITH DISLOCATIONS. NEW REVISION CONVERTING HIP TO DUAL MOBILITY WAS DETERMINED TO BE NEEDED TO SOLVE PATIENT DISLOCATIONS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP. THIS REPORT CAPTURES THE SURGERY NEEDED DUE TO DISLOCATIONS IS CAPTURED. THE OTHER REVISION TO ADDRESS THE METALLOSIS IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 23895928 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HIP WAS DISLOCATED. UPON VIEW OF THE PATIENT X-RAY, IT WAS FOUND THAT THE ACETABULAR COMPONENT WAS MALPOSITIONED. THE CUP WAS VERTICAL AND DR. WANTED TO REVISE THE ACETABULAR COMPONENT. WHEN ASKED IF HE HAD ANY INFORMATION ON THE PATIENT'S INITIAL SURGERY, HE SAID HE DIDN¿T HAVE ANY OF THE INFORMATION. HE WAS UNSURE OF WHERE THE PATIENT HAD THEIR SURGERY, WHO DID IT, OR WHEN IT WAS DONE. THE CUP WAS REMOVED AND THE PATIENT WAS PREPARED AND IMPLANTED WITH A REVISION MULTIHOLE CUP. AN ELEVATED RIM LINER WAS IMPLANTED AND A TRIAL REDUCTION WAS PERFORMED. STABILITY WAS CONFIRMED, SO THE REAL TS CERAMIC HEAD WAS OPENED AND IMPLANTED. HIP WAS REDUCED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23863767 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISING HEAD AND LINER TO LENGTHEN AND PROVIDE MORE OFFSET. DOI- (B)(6) 2024. DOR- (B)(6) 2025. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23837506 ↗
• InjuryDec 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A HEAD AND LINER TO ADD LENGTH AND OFFSET AFTER PATIENT DISLOCATED MULTIPLE TIMES. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23704258 ↗
• InjuryNov 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IMPLANT DISLOCATED, THE SURGEON WANTED DUAL MOBILITY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23607036 ↗
• InjuryNov 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HIP HAD DISLOCATED A FEW TIMES ACCORDING TO THE SURGEON. THEY DECIDED TO REPLACE THE NEUTRAL LINER WITH A LIPPED LINER AND THE APPROPRIATE SIZE HEAD. THEY SAID THAT ALL THE COMPONENTS LOOKED LIKE THEY WERE IN THE CORRECT ORIENTATION AND THAT PATIENT MAY JUST BE NON-COMPLIANT. DOI: ON (B)(6) 2020, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23454728 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, SO THE JOINT WAS WASHED OUT AND NEW HEAD AND LINER WAS IMPLANTED. NO ADVERSE SITUATION. NO ALLEGATIONS TOWARDS PRODUCTS REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23450559 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT¿S HIP WAS IMPINGING ANTERIORLY. LINER AND HEAD WERE EXTRACTED. DUAL MOBILITY WAS IMPLANTED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 23439422 ↗