PINNACLE 1217-25-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 735 adverse event reports that list this exact device (DI 10603295009900), received between Jan 31, 2013 and Sep 16, 2026 — classified as 714 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (146 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 735 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient came in with an infected right hip. The patient had all hip implants and placing cement spacer removed. There was no delay in case.DOI- (b)(6)2021.DOR- (b)(6)026.Affected side- Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50791121 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that infected wash out and head/liner exchange.Affected Side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50455360 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25692688 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25540686 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25540685 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PT. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25540671 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TOTAL HIP WAS UNSTABLE. CONVERTED TO DUAL MOBILITY AND LONGER HEAD. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25055238 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 25013749 ↗
• InjuryMar 30, 2026Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A LOOSENING OF CUP WITH NO OBSERVED BONE INGROWTH. X-RAYS SHOWED MOST SCREWS HAD BEEN PULLED FROM THE BONE AND THE CUP HAD SHIFTED VERTICALLY. ACTIVITY LEVEL - YES DOI- (B)(6) 2024, DOR-(B)(6) 2026, AFFECTED SIDE-LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24734908 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AN INFECTED HIP. ALL PRODUCTS WERE REMOVED FOR A SPACER. NO HARM WAS DONE ALL PIECE WERE REMOVED. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24532277 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL ATHA. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24524418 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL ATHA. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 24524417 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE IMPLANTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24428784 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A PREEXISTING INFECTION. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24364773 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. THE DEVICES WERE EXPLANTED AND A SPACER WAS IMPLANTED. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24323746 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AVN OF THE FEMORAL HEAD AND HAD A TOTAL HIP DONE ON (B)(6) 2025. OVER THE PAST MONTH, THE PATIENT HAS FALLEN MULTIPLE TIMES AND HAS NOW FRACTURED THEIR PELVIS AND BROKE THEIR CUP LOOSE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24210100 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AVN OF THE FEMORAL HEAD AND HAD A TOTAL HIP DONE ON (B)(6) 2025. OVER THE PAST MONTH, THE PATIENT HAS FALLEN MULTIPLE TIMES AND HAS NOW FRACTURED THEIR PELVIS AND BROKE THEIR CUP LOOSE. ACTIVITY LEVEL: YES. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24210099 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AVN OF THE FEMORAL HEAD AND HAD A TOTAL HIP DONE ON (B)(6) 2025. OVER THE PAST MONTH, THE PATIENT HAS FALLEN MULTIPLE TIMES AND HAS NOW FRACTURED THEIR PELVIS AND BROKE THEIR CUP LOOSE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24210097 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AVN OF THE FEMORAL HEAD AND HAD A TOTAL HIP DONE ON (B)(6) 2025. OVER THE PAST MONTH, THE PATIENT HAS FALLEN MULTIPLE TIMES AND HAS NOW FRACTURED THEIR PELVIS AND BROKE THEIR CUP LOOSE. ACTIVITY LEVEL: YES. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24210096 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24079526 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISLOCATION AND FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 24069247 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ITEMS EXPLANTED DUE TO UNSTABLE CUP. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 23996972 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ON DIALYSIS, FELL AND BROKE HER HIP IN JUNE. A TOTAL HIP WAS DONE THEN; SHE HAD A LINER AND HEAD REVISION ON (B)(6) 2025 BECAUSE SHE DISLOCATED MULTIPLE TIMES. SOMEWHERE BETWEEN (B)(6) 2025 AND TODAY SHE DISLOCATED AGAIN. SHE WAS NOT AT THE HOSPITAL FOR HIP PAIN BUT THEY TOOK AND X RAY ANYWAY AND FOUND IT TO BE DISLOCATED. PATIENT ALSO HAD WHAT WAS BELIEVED TO BE A SINUS TRACK ON HER SCAR SO THE DOCTOR DECIDED TO DO AN EXPLANT WITH GIRDLE STONE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 23974287 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED ABOUT 4 WEEKS POST OP. DOCTOR OPTED TO PULL HARDWARE, RUN LABS AND USE AND MEDICATED TEMP SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23888264 ↗
• 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: JUNE 13, 2023, DOR: NOVEMBER 4, 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23821865 ↗