PINNACLE 1217-40-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10603295010395), received between Jul 19, 2017 and Apr 27, 2026 — classified as 119 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (26 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 127 reports, in the reporter's own words as published by the FDA.

• 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 (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 25006692 ↗
• 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 24079707 ↗
• 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 23996929 ↗
• InjuryDec 17, 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 IMPLANTS WERE REMOVED AND PROSTALAC WAS INSERTED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23826509 ↗
• 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 (B)(6) 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 (B)(6), 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 23526206 ↗
• InjuryOct 30, 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. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23423325 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP. SURGEON PERFORMED I&D AND EXCHANGED HEAD AND LINER. THERE WERE NO DELAYS OR COMPLAINTS, AND NO HARM TO THE PATIENT. THERE WERE NO ISSUES WITH THE CUP. IT WAS NOT REVISED. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22653507 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS REVISED ALL THE IMPLANTS TO A CEMENT SPACER DUE TO AN ACTIVE INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21910380 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION OF ALL THE IMPLANTS DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21345753 ↗
• 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 21342929 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT WAS STILL SHOWING SIGNS OF INFECTION. SO, THE DOCTOR PERFORMED A FIRST STAGE REVISION BY REMOVING EVERYTHING, WASHING IT OUT EXTENSIVELY AND PUTTING NEW IMPLANTS IN. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20601867 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2024, THE PATIENT HAD A POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATED THAT DUE TO THE OVERLAP OF ABDOMINAL TISSUE, THE INCISION SHOWS A COUPLE AREAS THAT LOOK MOIST AND MACERATED. THE PATIENT WAS TOLD TO TAKE ORAL ANTIBIOTICS AND EDUCATED TO KEEP THE WOUND DRIER BY COVERING WITH A LIGHT GAUZE. ON (B)(6) 2024, THE PATIENT HAD ANOTHER POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATES THAT SHE HAD UNDERGONE AN EXPLORATION AND DEBRIDEMENT OF THE WOUND AND ¿THEN IT WAS JUST A SUPERFICIAL WOUND.¿ SHE CONTINUES TO HAVE A SMALL AREA ON THE MEDIAL SIDE WHICH WAS DEBRIDED ¿A BIT LAST TIME¿ AND IS SLOWLY HEALING. THE PATIENT IS OTHERWISE HEALING AND PROGRESSING WELL.

  Patient problems: Impaired Healing

  MAUDE report 20504683 ↗
• InjuryOct 15, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PELVIC FRACTURE AND INFECTION. THERE WAS AN ACETABULAR CUP LOOSENING AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20451444 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP. IMPLANTS WERE REMOVED AND SPACER IMPLANTED. THERE WERE NO ADVERSE EVENTS OR ISSUES WITH EXPLANTED PARTS. NO DELAY IN PROCEDURE. IMPLANTS ARE NOT AVAILABLE FOR RETURN. DOI: UNKNOWN . DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20181703 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO MEDIAL ACETABULAR WALL FRACTURE. PREVIOUS REVISION OF PINNACLE CUP - UNKNOWN DATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19622823 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION AND NEW IMPLANTS WERE IMPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18987511 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUG 02, 2023 GYNECOLOGICAL MEDICAL RECORDS REPORTED RIGHT HIP SURGERY INDUCED BLOOD CLOT IN 2019. THERE WAS NO SPECIFICS PROVIDED. THERE WAS NO MENTION OF ANY INTERVENTIONS

  Patient problems: Hematoma

  MAUDE report 18525251 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT HEAD OF SCREW BROKE DURING INSERTION. SCREW WAS LEFT IN PATIENT, BUT HEAD OF SCREW WAS REMOVED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18256488 ↗
• InjuryNov 3, 2023Migration; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 18066215 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, SURGEON REMOVED ACETABULAR COMPONENTS AND REPLACED WITH NEW COMPONENTS INCLUDING CONSTRAINED LINER. ACTIVITY LEVEL - YES. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17191744 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES SUBSEQUENT DISLOCATION POST REVISION ON (B)(6) AND (B)(6) LEADING TO RE-REVISION OF THE LEFT HIP. PLAINTIFF ALSO SUFFERED INJURY TO HIS MUSCLE, TISSUE, SCAR TISSUE FORMATION, PAINFUL DISLOCATION, EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6); DOR: (B)(6); LEFT HIP SECOND REVISION.

  Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16743634 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REQUESTED POLY LINER FOR REVISION OF PINNACLE METAL ON METAL LINER AND STEM REPLACEMENT IN ANTICIPATION OF LOOSENING DUE TO INCREASE ION LEVELS. TISSUES APPEARED NORMAL COLOR AND STEM WELL FIXED FROM POINT OF VIEW THROUGHOUT PROCEDURE. NO SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2021. UNKNOWN AFFECTED SIDE.

  Patient problems: Adhesion(s); Bone Fracture(s); Depression; Discomfort; Distress; Foreign Body Reaction; Loss of Range of Motion; Muscular Rigidity; Osteolysis; Pain; Pocket Erosion; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 16495996 ↗
• InjuryOct 31, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF PINNACLE SECTOR GRIPTION DUE TO FRACTURE IN POSTERIOR WALL. THE PATIENT HAD A TOTAL HIP ARTHROPLASTY ON (B)(6) 2022 WITH ACTIS STEM, ARTICULEZE CERAMIC HEAD, PINNACLE SECTOR GRIPTION CUP, 2 SCREWS AND A PINNACLE NEUTRAL LINER. THE POSTERIOR WALL OF HER ACETABULUM FRACTURED AND THE CUP BECAME DISLODGED. THE SURGEON REMOVED ALL DEPUY IMPLANTS. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 15699043 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHEN OPERATION AS NORMAL PROCEDURE, THE ACTUATOR CERAMIC LINER / CUP / HIP SCREW IS DAMAGED AND PRODUCTS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000306 ↗
• InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT RESENTED WITH PAIN AND UPON X-RAY AND INVESTIGATION, CUP APPEARED LOOSE AT BONE TO IMPLANT INTERFACE. SURGERY WAS PERFORMED , REPLACING CUP WITH LARGER SIZE AND FITTED THE DUAL MOBILITY SYSTEM. PATIENT APPEARED TO HAVE EXCELLENT FIXATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14102735 ↗