PINNACLE 1217-15-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 251 adverse event reports that list this exact device (DI 10603295009306), received between Jan 9, 2017 and Jun 17, 2026 — classified as 1 death, 241 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (49 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 251 reports, in the reporter's own words as published by the FDA.

• 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 25540764 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY DUE TO EHLERS-DANLOS SYNDROME, DYSPLASTIC AND DEGENERATIVE RIGHT HIP. ON (B)(6) 2025, PATIENT UNDERWENT A REVISION, RIGHT TOTAL HIP ARTHROPLASTY DUE TO PAIN, METAL ON METAL WEAR WITH ELEVATED METAL ION LEVELS PRIOR SPINAL FUSION. DOI: (B)(6) 2010. DOR: (B)(6) 2025. AFFECTED SITE: RIGHT HIP. THE RELATED COMPLAINT (B)(4) CAPTURES REVISION OF THE LEFT HIP DUE TO ELEVATED IONS AND PERSISTENT PAIN.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 25006631 ↗
• 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 24736427 ↗
• 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 24733772 ↗
• 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 24733583 ↗
• 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: ON (B)(6) 2024, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24733504 ↗
• 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 24323834 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE "PINN MULTIHOLE W/GRIPTION 48MM"? - UNFORTUNATELY THE LOT NUMBER WASN'T LEGIBLE. 2.VWHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? -LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24144735 ↗
• 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 24079488 ↗
• InjuryDec 10, 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 CHRONICAL INFECTION. SURGEON REMOVED IMPLANTS AND DID PLACEMENT OF A TEMPORARY SPACER UNTIL HEALING. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23773707 ↗
• InjuryDec 10, 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 CHRONICAL INFECTION. SURGEON REMOVED IMPLANTS AND DID PLACEMENT OF A TEMPORARY SPACER UNTIL HEALING. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23773705 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM SAINT VINCENT HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER 81, 70-YEAR-OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 23526144 ↗
• InjurySep 11, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE LEFT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23025238 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22176330 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22176254 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22176017 ↗
• 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: 10/23/2024.

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

  MAUDE report 22161414 ↗
• 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 22161408 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PRESUMED INFECTION SO THE SURGEON DECIDED TO WASH OUT AND REMOVE ALL THE IMPLANTS. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22004949 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED HIP. SURGEON CONDUCTED A 1 STAGE REVISION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21880981 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. ALL COMPONENTS (EXCEPT CUP) WERE REMOVED AND NEW IMPLANTS WERE INSERTED AFTER IRRIGATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687094 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. ALL COMPONENTS (EXCEPT CUP) WERE REMOVED AND NEW IMPLANTS WERE INSERTED AFTER IRRIGATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687092 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. ALL COMPONENTS (EXCEPT CUP) WERE REMOVED AND NEW IMPLANTS WERE INSERTED AFTER IRRIGATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687091 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TOTAL HIP ON (B)(6) 2024. PATIENT BECAME INFECTED AND HAD A HEAD & LINER EXCHANGE ON (B)(6) 2025. PATIENT RETURNED WITH ANOTHER INFECTION FOR A FULL REVISION. NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES AFFECTING THE PATIENT BECAUSE OF THE REPORTED EVENT. NO FURTHER INFORMATION WAS PROVIDED FOR REPORTING. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21552753 ↗
• InjuryFeb 10, 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 AND THE SURGEON DID A SINGLE STAGE REVISION. SURGEON REMOVED ALL IMPLANTS, DID A THOROUGH I&D, AND PUT IN NEW IMPLANTS. THERE WAS NO DELAY IN PROCEDURE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21342930 ↗