PINNACLE ALTRX 1221-40-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10603295393344), received between Dec 29, 2017 and Sep 29, 2026 — classified as 72 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 79 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50935280 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RTHA ON (B)(6) 2024 DUE TO A FEMORAL NECK FRACTURE. THEY PRESENTED WITH AN INFECTION. THE HEAD AND LINER WERE REPLACED IN ORDER TO WASH OUT THE INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24210491 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  VOLUNTARY REPORT RECEIVED (MW5178318). I AM REPORTING SERIOUS HARM AND PRODUCT TRACEABILITY ISSUES INVOLVING HIP IMPLANTS USED IN TWO SEPARATE SURGERIES THAT APPEAR TO INVOLVE JOHNSON & JOHNSON/DEPUY SYNTHES DEVICES. BOTH SURGERIES RESULTED IN COMPLICATIONS, PAIN, AND DISABILITY, AND IN BOTH CASES THE IMPLANTS LACKED PROPER IDENTIFICATION OR TRACEABLE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION. FIRST SURGERY Â (B)(6) 2024 ((B)(6) HOSPITAL, MD): A JOHNSON & JOHNSON/DEPUY REPRESENTATIVE NAMED (B)(6) WAS PRESENT IN THE OPERATING ROOM. THE SURGEON SIGNED OFF ON THE IMPLANT EVEN THOUGH THE IMPLANT SHEET DID NOT CONTAIN SPECIFIC SERIAL OR UNIQUE DEVICE IDENTIFIER (UDI) NUMBERS. THE IMPLANT HAD NO IDENTIFIABLE MARKINGS, MAKING IT COMPLETELY UNTRACEABLE. THIS VIOLATES STANDARD FOOD AND DRUG ADMINISTRATION (FDA) AND HOSPITAL TRACEABILITY RULES. POST-OPERATIVELY, I EXPERIENCED PAIN, INSTABILITY, AND NUMBNESS IN MY LEG. WHEN LATER REVISION SURGERY WAS PERFORMED, THE IMPLANT WAS FOUND TO BE AT A 36-DEGREE ANGLE, IMPROPERLY FITTED, AND FRACTURED, CONFIRMING MECHANICAL AND QUALITY FAILURE. SECOND (REVISION) SURGERY Â (B)(6) 2025 ((B)(6) HOSPITAL, (B)(6)): THE REVISION SURGEON, DR. (B)(6), DOCUME

  Patient problems: Joint Laxity; Loss of Range of Motion; Numbness; Pain

  MAUDE report 24122210 ↗
• InjuryDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT WAS UNSTABLE WITH DISLOCATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE CUP, LINER, FEMORAL HEAD AND ONE (1) SCREW WERE REMOVED AND REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23935277 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) 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.

  Patient problems: Unspecified Infection

  MAUDE report 23479073 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) 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 PAIN.

  Patient problems: Pain

  MAUDE report 23466923 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED OF HIP. HEAD AND LINER WERE EXCHANGED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22292445 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I & D OF INFECTED SURGICAL SITE. THERE WAS POLY SWAP AND HEAD LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22286227 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP WASHOUT DEBRIMENT WITH HEAD AND LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22210444 ↗
• InjuryJun 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL SURGEON AND SURGERY DATE UNKNOWN, AS IT WAS DONE IN ANOTHER STATE. PATIENT WAS HAVING DISLOCATIONS SO A DUAL MOBILITY CONSTRUCT WAS PUT IN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22187304 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMINDER IN THE HEAD WERE REMOVED TO DO INFECTION AND THE SAME COMPONENTS WERE PUT BACK IN PLACE AFTER FULL DEBRIDEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21889997 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY. IT WAS FURTHER REPORTED THAT INFECTION WAS UNABLE TO BE DETERMINED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21524800 ↗
• InjuryJan 22, 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 INFECTION. POLY AND HEAD EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21210857 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON ABOUT (B)(6) 2023, THE PATIENT DEVELOPED DRESS SYNDROME FOLLOWING THE REVISION AND DEVELOPED A FEVER AND MORE DRAINAGE AND WAS HOSPITALIZED. ON (B)(6) 2023, THE PATIENT HAD A REVISION LEFT TOTAL HIP WITH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF ANTIBIOTIC SPACER WITH ANTIBIOTIC BEADS TO ADDRESS INFECTED LEFT TOTAL HIP. DURING THE SURGERY, THE SURGEON OBSERVED CLEAR BONE DISEASE FROM THE PATIENT¿S UNDERLYING MOM FAILURE WITH DEAD BONE OF THE GREATER TROCHANTERIC REGION WITH NO ABDUCTORS, WHICH WAS ALSO SEEN DURING THE PREVIOUS REVISION FROM (B)(6) 2023. THE FEMORAL BONE APPEARED TO BE HARBORING CHRONIC OSTEOMYELITIS AND THERE WAS MICRO FRACTURING AROUND THE GREATER AND LESSER TROCHANTER AS THE BONE WAS EXTREMELY PAPER THIN. THE CUP, SCREW, LINER, HEAD, AND STEM WERE REMOVED. POSSIBLE OSTEOMYELITIS WAS OBSERVED. IT WAS ALSO NOTED THAT GAUGE WIRES WERE USED TO HOLD BONE FRAGMENTS IN POSITION. MEDICAL RECORDS NOTE THAT THE COMPONENTS REMOVED WERE DE PUY PRODUCTS ALONG WITH COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Fever; Fluid Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21147454 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE INCREASED PAIN AROUND HIP AND LOW GRADE FEVER CAME TO THE ER AND WAS NOTED TO HAVE PURULENT WOUND DRAINAGE EVENTUALLY UNDERWENT LEFT HIP IRRIGATION AND DEBRIDEMENT WITH LINER EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEAD SPACER. DOI: (B)(6) 2023 (LINER & SLEEVE). DOR: (B)(6) 2023 (LINER & SLEEVE). AFFECTED SIDE: LEFT HIP.

  Patient problems: Fever; Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 21147394 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE HEAD AND LINER WERE CHANGE DUE TO HIP HEMATOMA. THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hematoma

  MAUDE report 21104109 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT HAD AN INFECTED WOUND. POLY AND HEAD WERE EXCHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20745284 ↗
• MalfunctionOct 31, 2024Difficult to Insert; Improper or Incorrect Procedure or Method; Difficult to Insert; Improper or Incorrect Procedure or Method

  SURGEON DAMAGED LINER AFTER IMPLANTING. COULD HAVE JEOPARDIZED THE IMPLANT'S LOCKING MECHANISM.

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

  MAUDE report 20576767 ↗
• InjuryOct 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED: A. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - NO. B. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO, POST-SURGERY. C. PLEASE CONFIRM HOW MANY TIMES THE PATIENT WAS DISLOCATED. - JUST ONCE. D. WAS THERE PREVIOUS REVISION/S DUE TO MULTIPLE DISLOCATIONS? IF YES, WAS THIS REPORTED? PLEASE PROVIDE THE REFERENCE NUMBER. IF NOT, PLEASE PROVIDE FURTHER DETAILS. - NO, THE PATIENT DISLOCATED ONCE AFTER FALLING AND COULD NOT BE RELOCATED VIA CLOSED REDUCTION. E. PLEASE CONFIRM IF THE PREVIOUS DISLOCATIONS INVOLVED DEPUY PRODUCTS. IF YES, PLEASE PROVIDE THE DETAILS. - NO PREVIOUS DISLOCATIONS.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 20407728 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH HEAD AND LINER, DUE TO ACUTE INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20242010 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19808546 ↗
• MalfunctionJun 7, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULDN¿T LOCK. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19486529 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE INSTABILITY. SO THE SURGEON REMOVED THE LINER AND CONVERTED IT TO A DUAL MOBILITY TO HELP WITH STABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19304113 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER CHANGE WERE PERFORMED FOR SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM THE INFECTION, BUT THERE WAS NO DELAY AND NO BROKEN PIECES. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19260638 ↗
• InjuryMar 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION SWITCHED TO A DUAL MOBILITY OPTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18861607 ↗