PINNACLE Hip Solutions 1218-62-053Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295520320), received between Jun 9, 2023 and Sep 5, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, THE HEAD, LINER AND PROXIMAL BODY WERE REMOVED AND REPLACED AFTER WASHOUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22979716 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2012, THE PATIENT RECEIVED A RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY TO ADDRESS RIGHT HIP OSTEOARTHRITIS. METAL ON METAL IMPLANTS WERE IMPLANTED. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ALVAL PSEUDOTUMOR, METALLOSIS, OSSEUS BONE EROSIONS, AND OSTEOLYSIS. THE METAL INSERT AND HEAD WERE REPLACED WITH A DUAL MOBILITY LINER CONSTRUCT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, THE PATIENT'S RIGHT HIP WAS REVISED AGAIN TO ADDRESS PURULENT WOUND DRAINAGE, POSSIBLE INFECTION VERSUS ALVAL LESION. CULTURES OBTAINED WERE INCONSISTENT WITH INFECTION, SO THE DIAGNOSIS LEANED IN FAVOR OF ALVAL, SUBSEQUENT TO THE PREVIOUS REVISION. SURGEON REVISED AND REPLACED THE FEMORAL HEAD AND THE DUAL MOBILITY METAL AND POLY LINERS, RETAINING THE ACETABULAR CUP AND FEMORAL STEM. AND EXTENSIVE IRRIGATION AND DEBRIDEMENT WERE PERFORMED. THERE WERE NO COMPLICATIONS. THIS REPORT CAPTURES THE REVISION PROCEDURE ON (B)(6) 2024. THE PREVIOUS REVISION IS CAPTURED ON RELATED COMPLAINT (B)(4). DOI: (B)(6) 2012 DOI: (B)(6) 2024 DOE: (B)(6) 2024

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 22161453 ↗
• InjuryFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS PRESENT WITH A DISLOCATED HIP POST REVISION THA. THE SURGEON PERFORMED REPEATED ROM INTRAOPERATIVELY AND COULD NOT DETERMINE HOW THE PATIENT WAS DISLOCATING. THE SURGEON CHOSE TO CONSTRAIN THE HIP AS THIS IS NOW HER SECOND TIME DISLOCATING. THE SURGEON STATED THAT HE COULD ONLY BELIEVE THAT PATIENT'S ABDUCTORS WERE JUST TOO WEAK AFTER REPEATED HIP SURGERIES AS ROM SHOULD PROVIDE NO INSTABILITY NOR IMPINGEMENT. THERE WAS NO DELAY AND NO PATIENT HARM WAS REPORTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21402667 ↗
• InjuryJan 2, 2025Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENT POST REVISION THA WITH A DISLOCATED HIP. AFTER APPROPRIATE EXPOSURE HAS TAKEN PLACE, THE HIP IS RELOCATED AND FOUND TO BE EXTREMELY STABLE, BEING ABLE TO BE BOTH INTERNALLY AND EXTERNALLY ROTATED TO EXTREME POSITIONS WITHOUT DISLOCATING. FROZEN SECTION DID SHOW 5 WHITE CELLS PER HIGH POWERED FIELD WHICH WAS SOMEWHAT CONCERNING. A THOROUGH I&D IS PERFORMED DUE TO THIS FINDING AND ELEVATED LABS AND RESORBABLE ANTIBIOTIC BEADS ARE PLACED. NEW COMPONENTS ARE PLACED WITH NO PATIENT HARM OR DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 21060087 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH PUS DRAINAGE POSTOPERATIVELY FROM A REVISION THA. THE SURGEON PERFORMED AN EXTENSIVE I&D WITH EXCHANGE OF MODULAR COMPONENTS AND PLACEMENT OF ANTIBIOTIC RESORBABLE BEADS IN A DUAL SET UP. ALL COMPONENTS WERE WELL FIXED AND WELL FUNCTIONING. THERE WAS NO DELAY NOR PATIENT HARM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 20746658 ↗
• InjuryNov 1, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT HAD A PINNACLE MODULAR MOM LINER REVISION, CONVERTED TO A PINNACLE DUAL MOBILITY ON (B)(6) 2024. THE PATIENT RETURNED TO SURGERY FOR A WASHOUT AND THE PDM IMPLANTS WERE REPLACED AND THE JOINT DEBRIDED AND WASHED OUT. IT IS CURRENTLY UNCLEAR IF THERE IS AN INFECTION, THE LABS ARE PENDING. THERE WERE NO BROKEN INSTRUMENTS, THERE WERE NOT DELAYS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20588096 ↗
• InjuryAug 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19999326 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LOOSE INTERFACE WAS THE CUP AND THE ACETABULUM.

  Patient problems: Joint Laxity

  MAUDE report 19455366 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17491207 ↗
• InjuryJul 6, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT HAD A REVISION LEFT HIP WITH REMOVAL OF ACETABULAR CUP, SCREWS X5, AND PLACEMENT OF COMPETITOR CUP AND SCREWS X4, ALONG WITH DEPUY FEMORAL HEAD. PRIOR TO SURGERY, THE PATIENT WAS EXPERIENCING INSTABILITY. DURING THE PROCEDURE, THE SURGEON OBSERVED WEAKNESS OF THE GLUTEUS MAXIMUS MUSCLE. THE DUAL MOBILITY HEAD WAS REVISED, ALONG WITH THE LINER. DOI: (B)(6) 2022; DOR: (B)(6) 2023; LEFT HIP.

  Patient problems: Fall; Fatigue; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 17266341 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17097085 ↗