PINNACLE Hip Solutions 1218-50-043Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295520184), received between Mar 30, 2021 and Sep 2, 2026 — classified as 31 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50569569 ↗
• InjuryJul 29, 2026Device Dislodged or Dislocated

  It was reported that dislocating hip.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50077813 ↗
• InjuryApr 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTED IN OFFICE FOR FOLLOW UP POST DISLOCATION AND PAIN. X-RAYS REVEALED ECCENTRICITY OF THE IMPLANT POST HIP RELOCATION AND THE SURGEON SUSPECTED A HEAD-LINER DISASSOCIATION DURING THE ATTEMPTED RELOCATION. REVISION TOTAL HIP ARTHROPLASTY WAS SCHEDULED, AND INTRAOPERATIVELY, THE POLY LINER WAS FOUND DISASSOCIATED WITH LOOSENING AT THE NON-CEMENTED INTERFACE. BOTH THE LINER AND A WELL-FIXED FEMORAL HEAD WERE REMOVED DUE TO POTENTIAL DAMAGE, ALONG WITH THE METAL DM LINER. NEW COMPONENTS WERE IMPLANTED WITHOUT DELAY OR PATIENT HARM, AND HIP RANGE OF MOTION WAS STABLE POST-PROCEDURE. IT IS BELIEVED THE POLY LINER DISASSOCIATION OCCURRED DURING THE ATTEMPTED RELOCATION, AS PREVIOUS IMAGING SHOWED ALL COMPONENTS WELL FIXED AND FUNCTIONING. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 24971556 ↗
• InjuryMar 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24558104 ↗
• InjuryDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR UNSTABLE CUP. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23770309 ↗
• InjurySep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED, SHOWED UP TO DR OFFICE, SCHEDULE THE REVISION 8/18. FOUND THAT THE 22 CERAMIC HEAD CHIPPED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 22976262 ↗
• InjuryAug 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SO WENT TO CONSTRAINED LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22750877 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO PATIENT'S LEG LENGTH DISCREPANCY. SURGEON REVISED AND PUT IN A SHORTER CONSTRUCT. NO LOTS ABLE TO BE RETRIEVED FROM EACH IMPLANT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 22535000 ↗
• InjuryJun 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A KNEE AND HIP REPLACEMENT. THE HIP MALFUNCTIONED 2 YEARS LATER AND THE HIP WAS REPLACED, BUT IT AGAIN DISLOCATED. PATIENT DOES NOT HAVE THE ITEMS OR SERIAL NUMBERS.

  Patient problems: Joint Dislocation

  MAUDE report 22346277 ↗
• InjuryJun 25, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: MEDICAL RECORDS RECEIVED. THE PATIENT PREVIOUSLY UNDERWENT A PRIMARY HIP REPLACEMENT THAT USED A METAL-ON-METAL IMPLANT. OVER TIME, FRICTION BETWEEN THE METAL COMPONENTS CAUSED THE RELEASE OF MICROSCOPIC METAL DEBRIS INTO THE SURROUNDING TISSUES. THIS LED TO THE DEVELOPMENT OF METALLOSIS, AN INFLAMMATORY REACTION TO METAL PARTICLES. THE RESULTING INFLAMMATION PRODUCED A MASS IN THE HIP REGION THAT APPEARED SIMILAR TO A TUMOR ON IMAGING STUDIES, PROMPTING AN EVALUATION FOR POSSIBLE CANCER. FURTHER INVESTIGATION REVEALED THAT THE MASS WAS ACTUALLY A PSEUDOTUMOR¿AN INFLAMMATORY, NON-CANCEROUS GROWTH CAUSED BY THE METAL DEBRIS FROM THE IMPLANT. ADDITIONAL DIAGNOSES AND CONDITION EXPERIENCED FOUND, INFLAMED AND IRRITATED JOINT LINING, WEAR-AND-TEAR CHANGES, EVIDENCE OF OLD JOINT BLEEDING, SOME BONE AREAS WITH CELL DEATH (OSTEONECROSIS), A REMOVED PROSTHETIC JOINT COMPONENT, VESICULAR PALMOPLANTAR ECZEMA, IMPETIGO, SEBACEOUS CYST, TROCHANTERIC BURSITIS, COLITIS, MECHANICAL COMPLICATION OF PROSTHETIC JOINT IMPLANT, AND MECHANICAL COMPLICATION OF PROSTHETIC HIP IMPLANT. MRI ON (B)(6) 2024 SHOWS FINDINGS MOST SUGGESTIVE OF LEFT HIP SYNOVITIS, WITH A FLUID COLLECTI

  Patient problems: Colitis; Cyst(s); Distress; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; Pain; Skin Inflammation/ Irritation; Swelling/ Edema; Synovitis

  MAUDE report 22330508 ↗
• InjuryJun 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22143491 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED EXPLANTED / DUE TO INFECTION. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21657600 ↗
• InjuryJan 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE LINER WAS CONVERTED FROM A DUAL MOBILITY TO A CONSTRAINED LINER. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21079572 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THESE IMPLANTS DUE TO INFECTION, THEN THE SURGEON REPLACED THEM WITH NEW ONES. THE CUP AND SCREWS FROM THE PRIMARY SURGERY WERE LEFT IMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20371447 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, WASHED IT OUT, REMOVED DUAL MOBILITY LINER AND SHELL. RE-IMPLANTED SAME IMPLANTS AND CLOSED THE PATIENT UP. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20189199 ↗
• InjuryMay 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IS DISLOCATING HER HIP CONSTANTLY AND REQUIRES A REVISION. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 19325858 ↗
• MalfunctionJul 27, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY SURGERY, THE SURGEON ATTEMPTED TO IMPLANT COMPLAINED ITEM INTO THE ACETABULAR SHELL USING 32MM IMPACTOR TIP. AFTER FIRMLY IMPACTING COMPLAINED ITEM, THE SURGEON DEEMED IT REQUIRED FURTHER IMPACTION AS IT WAS NOT SEATING PROPERLY, AND SO RE-IMPACTED COMPLAINED COMPONENT INTO ACETABULAR SHELL. AFTER 3RD SERIES OF IMPACTIONS, THE ACETABULAR SHELL CAME LOOSE FROM THE ACETABULUM, WITH THE DUAL MOBILITY LINER STILL STUCK OFF AXIS INSIDE OF THE SHELL. SURGEON REMOVED THE ORIGINAL ACETABULAR COMPONENT WITH THE COMPLAINED DUAL MOBILITY LINER. THE SURGEON OPTED TO REAM THE ACETABULUM LARGER AND PUT IN A LARGER ACETABULAR COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17407712 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND SEROMA. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Seroma

  MAUDE report 17267114 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17191503 ↗
• MalfunctionMar 16, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PINNACLE DUAL MOBILITY LINER WOULD NOT SEAT INTO THE PINNACLE SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552856 ↗
• InjuryMar 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT UNDERWENT PRIMARY RIGHT THR ON (B)(6) 2009 WHERE A CORAIL STEM WITH A MOM PINNACLE LINER ARTICULATION WAS UTILIZED, DUE TO THE PATIENTS YOUNG AGE. PINNACLE MOM LINER WAS REMOVED AND PINNACLE DUAL MOBILITY LINER IMPLANTED. A NEW 22MM HEAD WAS IMPLANTED (SHELL AND STEM LEFT IN SITU) REVISION REPORTED PATIENT HAS SUBSEQUENTLY DISLOCATED 3X AND HAS BEEN REDUCED. A DECISION WAS MADE TO OPEN THE HIP AND IDENTIFY THE ISSUE. ON OPENING THE HIP THE HIP WAS RANGED THROUGH A ROM TO DETERMINE CAUSE OF DISLOCATION (THE HIP WAS DIFFICULT TO DISLOCATE AND REQUIRED AN EXTREME ROM TO DO SO). DR LIU ELECTED TO REMOVE THE PINNACLE SHELL AND LINER ALONG WITH THE DUAL MOBILITY HEAD AND REPLACE THE CUP WITH A ZM CUP AND ONE OF THEIR DUAL MOBILITY LINERS. DOI: (B)(6) 2022; DOR: (B)(6) 2023; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16522542 ↗
• InjuryJan 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16150332 ↗
• InjuryJan 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE DISLOCATING. NO LOOSENING AND SURGICAL DELAY WAS THERE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16137046 ↗
• InjuryJun 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF IMPLANTS. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14684782 ↗
• InjuryJun 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THE SURGEON REMOVED CUP, HEAD, AND LINER AND REPLACED WITH STRYKER DUAL MOBILITY. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14680618 ↗