PINNACLE ALTRX 1221-36-162Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295016458), received between Aug 18, 2017 and Apr 29, 2026 — classified as 23 injuries.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT IT HAD BEEN REVISED FOR A DISLOCATION. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25035170 ↗
• InjuryJan 8, 2026Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 24006433 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HEAD AND LINER EXCHANGE AND WASHOUT DUE TO SUSPECTED INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22796687 ↗
• InjuryDec 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 18307687 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2007, PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT USING S-ROM STEM AND PINNACLE CUP WITH METAL-ON-METAL ARTICULATION, TO ADDRESS END STAGE OSTEOARTHRITIS. THERE WAS NO REPORTED SURGICAL COMPLICATION. ON (B)(6) 2013, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ACUTE INFECTION. IRRIGATION AND DEBRIDEMENT WAS PERFORMED, WITH EXCHANGE OF ACETABULAR LINER AND FEMORAL HEAD. THERE WAS NO EVIDENCE OF METALLOSIS IDENTIFIED. THERE WAS EVIDENCE OF CORROSION ON THE STEM TRUNNION. THE CUP, HOLE ELIMINATOR, AND S-ROM STEM WITH SLEEVE WERE RETAINED. THERE WAS NO EVIDENCE OF OSTEOMYELITIS. ON (B)(6) 2023, PATIENT RECEIVED AN MRI OF THE RIGHT HIP. NO FINDINGS TO SUGGEST LOOSENING OF THE COMPONENTS OF THE RIGHT HIP IMPLANTS. OBSERVED 2 CM X 6 CM COMPLEX FLUID SIGNAL INTENSITY COLLECTION ALONG THE POSTERIOR MARGIN OF THE HIP JOINT AND PROXIMAL FEMUR. THIS COLLECTION COMMUNICATES WITH A DEFECT IN THE POSTERIOR PSEUDO CAPSULE AS WELL AS ABUTTING A CORTICAL DEFECT IN THE POSTERIOR ASPECT OF THE GREATER TROCHANTER. APPEARANCE SUGGEST ADVERSE TISSUE REACTION. IN THE APPROPRIATE CLINICAL CONTEXT INFECTION COULD HAVE A SIMILAR IMAGING APPEARANCE. CONSIDER ASPIRATION OF

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16951959 ↗
• InjuryFeb 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT HIP DISLOCATED. COMPONENTS WERE REMOVED. RE IMPLANTED WITH DIFFERENT COMPONENTS. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13618257 ↗
• InjuryDec 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF THE HIP DUE TO DISLOCATION AND LOOSENING. PATIENT DISLOCATED AND RETURNED BACK TO THE HOSPITAL, WHILE BEING RELOCATED BACK INTO POSITION A GT FRACTURE OCCURRED WHICH THEN ENABLED THE STEM TO LOOSEN IN THE FEMORAL CANAL. ORIGINAL SURGERY WAS DONE ON THE (B)(6) 2021 AT (B)(6) HOSPITAL BY DR. (B)(6). THE SIDE WAS THE RIGHT SIDE THAT HAS BEEN AFFECTED.

  Patient problems: Joint Dislocation

  MAUDE report 12961369 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION WAS DUE TO AN INFECTED HIP. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 12484872 ↗
• InjurySep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP REPLACEMENT DUE TO DISLOCATION. REVISION OF HEAD AND LINER TO A CONSTRAINED LINER, AS THE PATIENT DISLOCATED. THE PATIENT WAS NOT COMPLIANT WITH POST-OP INSTRUCTIONS. DOI: (B)(6) 2021, DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12448199 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. PLEASE PROVIDE PATIENT INITIAL. ANSWER: DO NOT HAVE THE INFORMATION FOR PATIENT. B. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS. ANSWER: NO PARTS WERE BROKEN.

  Patient problems: Pain

  MAUDE report 11713643 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT I&D FOR CONFIRMED INFECTION WITH HEAD AND LINER EXCHANGE. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT HIP.

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

  MAUDE report 11244337 ↗
• InjuryFeb 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HIP DONE ON (B)(6) 2019 BY THE DOCTOR AT (B)(6). PATIENT WAS SUFFERING FROM DISLOCATIONS. DOCTOR FELT IT WOULD BE BEST TO CONVERT THEIR LINER TO A CONSTRAINED LINER. THE 62X36 +4 10 DEGREE LINER WAS REMOVED, ALONG WITH A 36MM +12 CERAMIC HEAD. A 62X40MM +4 NEUTRAL CONSTRAINED LINER WAS IMPLANTED, WITH A 40MM +12 METAL HEAD. PATIENT WAS REDUCED AND FOUND TO BE STABLE. CLOSING PROCESS BEGAN. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9665170 ↗
• InjuryOct 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT TOTAL HIP REVISION TO ADDRESS HIP DISLOCATION. DATE OF IMPLANTATION: (B)(6) 2007. DATE OF REVISION # 1: (B)(6) 2017, (HEAD AND LINER). DATE OF REVISION # 2: (B)(6) 2019, (CUP, HEAD, AND LINER), (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 9156161 ↗
• InjuryMay 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AFTER THE FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8611549 ↗
• InjuryMay 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: NONE REPORTED (RIGHT HIP). PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8609120 ↗
• InjuryMar 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2012 - DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8424356 ↗
• InjuryNov 13, 2018Device Dislodged or Dislocated; Separation Problem; Device Dislodged or Dislocated; Separation Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION AND LINER DISASSOCIATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8063629 ↗
• InjurySep 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7896563 ↗
• InjurySep 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ORIGINAL COMPETITOR BIPOLAR IMPLANTED 8 YEARS AGO. ON (B)(6) 2018, CONVERTED TO A TOTAL WITH PINNACLE CUP/LINER CONSTRUCT. COMPETITOR FEMORAL IMPLANTS LEFT IMPLANTED. PATIENT HAS DISLOCATED. REMOVED WELL FIXED COMPETITOR'S STEM/HEAD CONSTRUCT DUE TO RETROVERSION. DOI: (B)(6) 2018, DOR: (B)(6) 2018, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7854995 ↗
• InjuryApr 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Not Applicable

  MAUDE report 7453711 ↗
• InjuryMar 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) 2018 MEDICAL RECORDS RECEIVED: AFTER THE REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND DISLOCATION. DOI: (B)(6) 2016; DOR: (B)(6) 2016; LEFT HIP. PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 7323160 ↗
• InjurySep 15, 2017Insufficient Device Problem Information; Noise, Audible; Insufficient Device Problem Information; Noise, Audible

  AUG 17, 2017: LEGAL MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES FATIGUE, PAIN, CLICKING SENSATION, LIMITED MOBILITY, HIGH COBALT LEVELS, INFECTION, AND PATHOLOGY REPORTS CONFIRMED PRESENCE OF PROPIONIBACTERIUM ACNES. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISION NOTES REPORTED NECROSIS, PURULENT APPEARING FLUID, SYNOVIAL TYPE LINING AND GRANULATION TISSUE WHICH APPEARS VERY THICKENED, REDDENED AND ABNORMAL, SMALL AMOUNT OF RESIDUAL CORROSION ON THE TAPER, LARGE LYTIC DEFECT. PATHOLOGIST DESCRIBES INCREASED ACUTE INFLAMMATION ALL CONSISTENT WITH INFECTION. MRI SHOWS HYPERINTENSE OSTEOLYSIS. LABORATORY RESULTS FOR COBALT-CHROMIUM SHOWED BELOW 7PPB. PART AND LOT INFORMATION FOR HEAD AND LINER WERE PROVIDED BUT NOT READABLE.

  Patient problems: Adhesion(s); Fatigue; Impaired Healing; Inflammation; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Necrosis; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 6869276 ↗
• InjuryAug 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS DISASSOCIATION.

  Patient problems: No Code Available

  MAUDE report 6804602 ↗