PINNACLE 1217-35-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 10603295010388), received between Apr 26, 2013 and Sep 15, 2026 — classified as 296 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (58 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 315 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was unstable.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Joint Laxity

  MAUDE report 50775224 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DOCTOR SWITCHED HEAD AND LINER TO GAIN STABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25110714 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE DOCTOR SWITCHED HEAD AND LINER TO GAIN STABILITY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25110691 ↗
• InjuryApr 30, 2026Osseointegration Problem

  IT WAS REPORTED THAT EMSYS LNR AOX ELV 52X36, UNK HIP FEMORAL HEAD CERAMIC, EMSYS SHL 3HOLE 52, PINN CAN BONE SCREW 6.5MMX35MM, AND UNKNOWN SCREW WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A PATIENT WHO UNDERWENT A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE DUE TO INFECTION FOLLOWING IMPLANTATION OF AN EMPHASYS CORAIL CONSTRUCT. DURING THE OPERATION, THE CUP WAS DESCRIBED AS LOOSE, BUT IT WAS NOT REMOVED BECAUSE THE PATIENT WAS LIKELY TO REQUIRE A MULTI-STAGE REVISION AND SCREWS WERE ALREADY IN PLACE. THE REPORTED FAILURE INCLUDED INFECTION AND IMPLANT LOOSENING. THE PATIENT EXPERIENCED HARM, REQUIRING REVISION OF THE LINER AND IMPLANTATION OF A NEW FEMORAL HEAD AS PART OF THE WASHOUT FOR INFECTION. EXTENDED HOSPITALIZATION WAS NECESSARY FOR SURGICAL INTERVENTION TO ADDRESS THE INFECTION. THE EVENT IS LIKELY TO RESULT IN FURTHER MULTI-STAGE REVISION PROCEDURES. THE IMPLANT STATUS FOR THE LINER AND FEMORAL HEAD IS EXPLANTED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25045991 ↗
• 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 24532282 ↗
• 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 24531869 ↗
• 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 24531841 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, EXPLANTED ALL COMPONENTS FOR I AND D. THERE WAS NO DELAY IN THE CASE, THERE WAS NO HARM DONE TO THE PATIENT, THERE WERE NO COMPLAINTS. I HAD NO FURTHER INFORMATION LAST REVISION WAS (B)(6) 25. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24531048 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY HAD TO EXPLANT ALL IMPLANTS BECAUSE PATIENT WAS UNSTABLE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24518204 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY HAD TO EXPLANT ALL IMPLANTS BECAUSE PATIENT WAS UNSTABLE DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24517923 ↗
• 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.WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? -LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24144701 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS UNSTABLE WITH DISLOCATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE CUP, LINER, FEMORAL HEAD AND ONE (1) SCREW WERE REMOVED AND REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23935236 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23926168 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC REMOVAL OF IMPLANTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Sepsis

  MAUDE report 23634140 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR HIP REVISION - INFECTION DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2025, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: ON (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 101854018, LOT NUMBER: 4442962, COMPONENT TYPE: STEM, DESCRIPTION: RECLAIM MONOBLOC REVISION STANDARD STEM 18 STANDARD OFFSET. CATALOG NUMBER: 473246028, LOT NUMBER: 4838000, COMPONENT TYPE: HEAD, DESCRIPTION: EMPHASYS 46 MM X 28 MM AOX MOBILE BEARING HEAD. CATALOG NUMBER: 472556046, LOT NUMBER: 4671538, COMPONENT TYPE: LINER, DESCRIPTION: EMPHASYS 56-58 MM X 46 MM DUAL MOBILITY LINER. CATALOG NUMBER: 471056300, LOT NUMBER: 4925729, COMPONENT TYPE: SHELL, DESCRIPTION: EMSYS SHL 3HOLE 56. CATALOG NUMBER: 121735500, LOT NUMBER: PU209417, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 35MM. CATALOG NUMBER: 121745500, LOT NUMBER: PU216737, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 45MM. CATALOG NUMBER: 136528310, LOT NUMBER: 4369950, COMPONENT TYPE: HEAD, DESCRIPTION:

  Patient problems: Unspecified Infection

  MAUDE report 23523151 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S HIP WAS DISLOCATED AND CONCERNS OF INFECTION. SURGEON REPLACED CUP, LINER AND HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23357374 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S HIP WAS DISLOCATED AND CONCERNS OF INFECTION. SURGEON REPLACED CUP, LINER AND HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23357372 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL HIP SURGERY DONE (B)(6) 2025 AT (B)(6) SURGERY CENTER BY DR. UNFORTUNATELY, THE PATIENTS HIP BECAME INFECTED. DR. OPTED TO DO AN IMMEDIATE EXCHANGE WHERE HE WAS GOING TO TAKE OUT ALL THE IMPLANTS, THOROUGHLY WASHOUT THE HIP, THEN IMPLANT NEW COMPONENTS. THE PATIENT WAS PREPPED WITH A 52MM EMPHASYS CUP, WHICH ALLOWED DR. TO UTILIZE A 40MM LINER FOR ADDED STABILITY. THE FEMORAL CANAL WAS THEN PREPPED FOR A 5HI STEM AND A TRIAL REDUCTION WAS PERFORMED WITH A 40MM +1.5 HEAD. DR. FELT THAT THE 40 +5 WAS BETTER AND IMPLANTED IT. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025, DOE: UNKNOWN, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23069116 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING CAME OUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22827762 ↗
• MalfunctionAug 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN OPENING THE PINNACLE MATERIAL DURING SURGERY, IT WAS FOUND THAT THERE WAS NOTHING INSIDE THE BOX. ONLY SEALED PACKAGING WAS DELIVERED. THE PACKAGING ONLY CONTAINED THE USER MANUAL, WHICH HAS A GREATER WEIGHT COMPARED TO THE ACTUAL WEIGHT OF THE SCREW. THERE IS NO POSSIBILITY OF VISUAL CONFIRMATION OR WEIGHING THE PRESENCE OF THE PRODUCT INSIDE THE PACKAGE BEFORE USE. TO ENSURE THE STERILITY OF THE MATERIAL, THE OPENING OF THE BOX OCCURS EXCLUSIVELY AT THE TIME OF THE SURGICAL PROCEDURE. THE ABSENCE WAS NOTICED ONLY AT THE HOSPITAL DURING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825947 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ACETABULAR COMPONENT WAS REVISED DUE TO ILIOPSOAS PAIN. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Pain

  MAUDE report 22793344 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUP, POLY, SCREWS, AND HEAD WERE REVISED FOLLOWING A PATIENT FALL THAT LEAD TO ACETABULAR FRACTURE. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22524214 ↗
• MalfunctionJul 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF THE 35MM ACETABULAR SCREW BROKE OFF WHILE INSERTING. THE SCREW WAS NOT CLOSE TO BEING SEATED AND ONLY MINIMAL TORQUE HAD BEEN APPLIED. THERE WAS NO PATIENT HARM. ALL PIECES WERE RETRIEVED. THERE WAS A THREE (3) MINUTE DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518855 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH REMOVAL OF HIP DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22481145 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS REMOVED DUE TO INFECTED HIP, PLACED PROSTHETIC, STEM, AND ALL POLY LINER. DOI: UNKNOWN. DOR: (B)(6) 2025 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22358860 ↗