PINNACLE Hip Solutions 1218-54-047Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295520283), received between Sep 17, 2021 and Sep 28, 2026 — classified as 45 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917969 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the head and liner were changed for suspected infection, possible metal-on-metal (MoM) reactivity, and a large fibrous fluid collection that was inconclusive with no way to confirm. DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 50071694 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25461498 ↗
• InjuryMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HIP REVISION DONE THE WEEK PRIOR AND THEY DISLOCATED POST OP WHILE STILL IN THE HOSPITAL. SURGEON OBSERVED THE PATIENT FOR A FEW DAYS, AND WHEN THEY DISLOCATED AGAIN, DECIDED TO REVISE. CHANGED OUT THE LINER/HEAD AND WENT WITH A LONGER HEAD; WAS VERY STABLE ON THE OR TABLE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24630087 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24214825 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23961414 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23853656 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE SURGEON PERFORMED HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23837616 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CUP AND LINER INSTABILITY, 25MM SCREW HEAD BROKE OFF WHEN TRYING TO EXTRACT SCREW. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23821880 ↗
• InjuryDec 1, 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. DOCTOR DID I&D HEADBALL LINER SWAP. NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23686832 ↗
• InjurySep 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND WENT TO 36 DM LONGER HEAD. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23040061 ↗
• InjuryAug 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 WITH HEAD AND LINER EXCHANGE DUE TO EARLY INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22879738 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CONVERSION FROM A GAMMA NAIL TO A THR. PATIENT GOT INFECTED 6 WEEKS POSTOPERATIVELY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22819971 ↗
• InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUFFERED A STROKE A MONTH AGO AND HAD FALLEN AND DISLOCATED TO HIP. THE SURGEON ELECTED TO CONVERT HER TO. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22811646 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT I/D WASHOUT. PATIENT WAS INFECTED. THERE WAS NO COMPLICATIONS DURING SURGERY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22631597 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOWING EARLY SIGNS OF INFECTION. HEAD AND LINER SWAP WAS DONE OUT OF AN ABUNDANCE OF CAUTION WHILE PERFORMING THE I&D FOR A POSSIBLY INFECTED HIP. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22422305 ↗
• InjuryMar 7, 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 PAIN. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21548059 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. UPON X-RAY, CUP FOUND TO HAVE BECOME LOOSE AND SHIFTED DUE TO A FRACTURE IN THE ACETABULAR AREA NOT RELATED TO SURGERY. STEM WAS WELL FIXED AND DID NOT REPLACE. SURGEON REAMED UP AND PLACED A MULTI HOLE CUP AND DUAL MOBILITY SYSTEM. PATIENT WAS LEFT SURGERY WILL FIXED AND STABLE. SURGEON WAS SATISFIED WITH SUCCESSFUL SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21255082 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION WHICH HAS MADE THEM VERY ILL. INFECTION IN THE JOINT HAS SINCE DEVELOPED, AS SURGEON NOTED PATIENT HAD BEEN DOING WELL BEFORE THE ABOVE INFECTION. A REVISION OF RIGHT THA DUE TO INFECTION FOLLOWING A DAIR WAS PERFORMED. PATIENT STILL HAD INFECTION AND REQUIRED FIRST STAGE REVISION TO REMOVE ALL COMPONENTS, WASH OUT AND DEBRIDEMENT. CEMENTED A 52 LINER AND SIZE 1 C STEM PLACED FOR APPROXIMATELY 6 WEEKS, AND WILL THEN FULLY REVISE.

  Patient problems: Unspecified Infection

  MAUDE report 21138856 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH HIP PAIN AND INABILITY TO BEAR WEIGHT. XRAYS SHOWED THAT THE ACETABULAR SHELL WAS NO LONGER IN PLACE AND IS THROUGH THE MEDIAL WALL. THERE WAS NON-CEMENTED LOOSENING OF THE ACETABULAR SHELL. THE PATIENT WAS ADMITTED AND SCHEDULED FOR SURGERY TO REMOVE EXISTING COMPONENTS. NO DELAY OR HARM WAS NOTED. THE PROXIMAL FEMORAL COMPONENT TO INCLUDE THE HEAD AND DM POLY LINER WERE REMOVED. ACETABULAR COMPONENT WAS ALSO REMOVED WITH NO COMPLICATION. DUE TO LACK OF BONE STOCK, NO COMPONENTS WERE REPLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20845131 ↗
• InjuryOct 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A REVISION SURGERY FOR DISLOCATION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20461494 ↗
• InjurySep 13, 2024Off-Label Use; Off-Label Use

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING TREATMENT/IMPACT ON THE PATIENT. ON IV ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 20215371 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 20 MAR 2024 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2023, THE PATIENT HAD A LEFT HIP ASPIRATE FOR LAB TESTING. THE PATIENT WAS REPORTED TO HAVE LEFT HIP PAIN. THE PATIENT REPORTS THAT THEIR HIP IS NOT PUFFY. CHROMIUM WAS NOTED TO BE 11.7 NG/ML AND COBALT 14.4 NG/ML. ON (B)(6) 2024 THE PATIENT WAS REPORTED TO HAVE A LEFT TOTAL HIP ARTHROPLASTY REMOVAL OF CUP AND STEM AND LEFT HIP INSERTION OF ANTIBIOTIC CEMENT SPACER. THE FINDINGS INCLUDED LEFT HIP METALLOSIS WITH BLACK/BROWN DEBRIS AND PURULENT MATERIAL UNDER THE LINER. IT WAS NOTED THAT THE FEMORAL STEM WAS WELL FIXED AND AN EXTENDED TROCHANTERIC OSTEOTOMY WAS NEEDED FOR REMOVAL AND IT TOOK 2 HOURS. DURING THE PROCEDURE, THE SURGEON OBSERVED PROXIMAL OSTEOLYSIS. TWO DALL MILES CABLES WERE PLACED AROUND PROXIMAL FEMUR TO REDUCE THE ETO FRAGMENTS TO THE SPACER. THE PATHOLOGY RECORDS REPORT THE DEPUY PRODUCTS REMOVED. MEDICAL/SURGICAL NOTES HAD DISCREPANCIES IN THE SIDE OF THE OPERATION, WITH PART OF THE SURGICAL NOTE STATING THAT THE SURGERY WAS ON THE RIGHT SIDE AND PART OF THE SAME SURGERY NOTES STATING THAT IT WAS THE LEFT. THERE WAS ZERO MENTION OF IT BEING BILATERAL.

  Patient problems: Erythema; Fall; Fatigue; Fluid Discharge; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 18912331 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. AN IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP

  Patient problems: Unspecified Infection

  MAUDE report 18722013 ↗
• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. BI-MENTUM LINER POPPED OFF OF 28 HEAD WHEN IT DISLOCATED. DOI: (B)(6), 2021. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18482834 ↗