PINNACLE 1217-20-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 590 adverse event reports that list this exact device (DI 10603295009795), received between Jun 27, 2017 and Sep 18, 2026 — classified as 2 deaths, 570 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (127 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 590 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50825716 ↗
• InjuryJun 10, 2026Osseointegration Problem

  IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE- LEFT HIP.

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

  MAUDE report 25461383 ↗
• InjuryJun 10, 2026Osseointegration Problem

  IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE- LEFT HIP.

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

  MAUDE report 25461247 ↗
• 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 25013776 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THA FOR FEMORAL NECK FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2026, THE SURGEON DETERMINED THAT THERE WAS A POSTOPERATIVE INFECTION, AND DEBRIDEMENT WAS PERFORMED ON THE SAME DAY. THE LINER AND HEAD WERE REPLACED AS THE SLIDING SURFACE AND THE INFECTION SITE WAS THOROUGHLY CLEANSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. IMPLANT DATE: (B)(6) 2025. EXPLANT DATE: (B)(6) 2026. (ONLY THE LINER AND HEAD WERE REPLACED).

  Patient problems: Unspecified Infection

  MAUDE report 24885487 ↗
• 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 24736446 ↗
• 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 24733602 ↗
• 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) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24531130 ↗
• 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) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24531101 ↗
• 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 24428656 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S JOINT SPACE WAS INFECTED. THEREFORE ALL HARDWARE WAS REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24086940 ↗
• 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: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23821879 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ORIGINAL CASE WAS DONE SEVEN YEARS AGO DUE TO INSTABILITY. PATIENT DISLOCATED PINNACLE CONSTRAINED LINER. DOCTOR STATED THAT THE CUP WAS NOT IN AN OPTIMAL POSITION AND WAS VERTICAL. THERE WAS VISIBLE IMPINGEMENT BETWEEN THE CUP AND TRUNNION. NOTICEABLE METALLOSIS ON THE TISSUES. DOCTOR CUT OUT THE PINNACLE CUP AND REPLACED IT WITH A READAPT CUP; REMOVED THE HEAD, CUP, LINER AND SCREWS. REPLACED WITH A +12 TO INSURE STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Laxity

  MAUDE report 23803864 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS INFECTED SO IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. ORIGINAL IMPLANT DATE - (B)(6) 2025. EXPLANT DATE (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 23647404 ↗
• InjuryNov 14, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WERE NO PATIENT CONSEQUENCE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23557082 ↗
• 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 (B)(4), 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 23526215 ↗
• InjuryNov 4, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ALL IMPLANTS APPEARED TO BE LOOSE. NO PATIENT COMPLICATIONS. AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23468022 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2025, THE IMPLANTS EXCEPT THE STEM WERE REMOVED, THE ACETABULAR SIDE CEMENT MOLD WAS REPLACED, AND THE HEAD WAS REUSED. DISEASE: RIGHT TOTAL HIP ARTHROPLASTY INFECTION. PROCEDURE: TOTAL HIP ARTHROPLASTY REVISION. IT WAS REPORTED THAT ON (B)(6) 2025, THE ACETABULAR SIDE WAS RECONSTRUCTED USING A PRODUCT FROM ANOTHER COMPANY, THE STEM WAS PRESERVED, AND THE HEAD WAS REPLACED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23027570 ↗
• InjurySep 11, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THERE WAS LOOSENING OF THE STEM AND CUP AT THE NON-CEMENTED INTERFACE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23025284 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA THA FOR OA ON HIP JOINT WITH THE PRODUCTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SALES REP WAS INFORMED THAT THE PATIENT IS SUSPECTED OF HAVING A DISLOCATION AND INFECTION, THEREFOR REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22998388 ↗
• InjuryJul 31, 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 PAINFUL HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22677844 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ACUTE HIP INFECTION AND SURGEON DECIDED TO PERFORM SINGLE STAGE REVISION. ALL IMPLANTS WERE REMOVED AND HIP I&D DONE. THERE WERE NO COMPLAINTS OR DELAYS. AFFECTED SIDE: LEFT HIP

  Patient problems: Unspecified Infection

  MAUDE report 22499694 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO PROSTALAC DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22336800 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AFTER PRIMARY HIP AND FRACTURED ACETABULUM. SURGEON REMOVED ALL IMPLANTS AND PUT IN NEW COMPONENTS. THERE WERE NO COMPLAINTS OR DELAYS. IMPLANTS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22100109 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED ALL PREVIOUS IMPLANTS AND IMPLANTED A SPACER DUE TO INFECTION. NO TIME ADDED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22077280 ↗