PINNACLE 1217-30-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 484 adverse event reports that list this exact device (DI 10603295010159), received between Jul 27, 2017 and Sep 18, 2026 — classified as 1 death, 463 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (103 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 484 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 50828429 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had prostalac spacer for infection, right hip. Removal of all implants from original surgery date of (b)(6) 2026. Affected side- Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50497518 ↗
• 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 50455320 ↗
• InjuryJul 8, 2026Osseointegration Problem

  IT WAS REPORTED THAT A FAILED PINNACLE CUP WITH ASSOCIATED ACETABULAR DEGENERATION WAS IDENTIFIED. THE ACETABULAR COMPONENT WAS EXPLANTED AND REPLACED WITH A CUSTOM TRIFLANGE ENOVIS IMPLANT. THE METAL FEMORAL HEAD WAS ALSO EXPLANTED AND REVISED WITH A TS CERAMIC FEMORAL HEAD. IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ACETABULAR CUP LOOSENING AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25751167 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI:(B)(6) 2026 DOR: (B)(6) 2026 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 25531875 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY OF THE HIP AND HAD TWO DISLOCATIONS. NO ALLEGATION AGAINST THE CUP. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25428320 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING DISCOMFORT AND IMPINGEMENT ISSUES, SO THE DOCTOR REVISED. NO KNOWN INFECTION PRESENT. NO DELAY IN SURGERY. DOI: (B)(6) 2017, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 25382283 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED HIP. IMPLANTS WERE REMOVED AND TEMPORARY SPACER IMPLANTED. THERE WERE NO DELAYS, COMPLAINTS, AND NO HARM TO THE PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25234075 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO JOINT INFECTION AND DISLOCATION, SCREW WAS REMOVED AND HEAD AND POLY WERE CHANGED FOR DUAL MOBILITY CONSTRUCT. ALL PARTS WERE INTACT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25149748 ↗
• InjuryApr 14, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD POSSIBLE LOOSENING, HEAD/LINER WAS EXCHANGED DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 24872063 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED DUE TO UNSTABLE HIP. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6), 2025 DOR: (B)(6), 2026 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24864113 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24800556 ↗
• 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 24518029 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO IMPLANT. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24269819 ↗
• 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 23888247 ↗
• 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 23773669 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ACATABULAR CUP LOOSENING AT THE BONE TO IMPLANT INTERFACE. REVISION OF ACETABULAR COMPONENT FOR PAIN AND SUSPECTED LOOSENING. THE CUP APPEARED TO BE WELL INGROWN INTRAOPERATIVELY. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 23732125 ↗
• InjuryNov 14, 2025Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 23557109 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 17 OCT 2025, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: ON (B)(6) 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD, LINER, SHELL). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 121722058, LOT NUMBER: M9551X, COMPONENT TYPE: SHELL, DESCRIPTION: PINNACLE SHELL SECTOR 58MM. CATALOG NUMBER: 136540730M LOT NUMBER: 4549269M COMPONENT TYPE: HEADM DESCRIPTION: BIOLOX DELTA REVISION HEAD 12/14 40MM +8.5, CATALOG NUMBER: 101012070M LOT NUMBER: 4724370M COMPONENT TYPE: STEMM DESCRIPTION: ACTIS COLLARED HIGH OFFSET FEMORAL STEM SZ 7, CATALOG NUMBER: 122140058, LOT NUMBER: M9976F, COMPONENT TYPE: LINER, DESCRIPTION: PINNACLE ALTRX 58MM X 40MM NEUTRAL. CATALOG NUMBER: 121730500, LOT NUMBER: PU236738, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 30MM.

  Patient problems: Unspecified Infection

  MAUDE report 23534205 ↗
• 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 23526199 ↗
• 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 23423357 ↗
• InjurySep 17, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF RIGHT HIP CUP IN 2023 BECAUSE OF EARLY LOOSENING OF CUP. THE LOOSENING OCCURRED BETWEEN THE METAL CUP AND THE BONE. THE PATIENT WAS SATISFIED WITH THE SURGICAL OUTCOME FROM 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23076382 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE CEMENTMOLD PLACED ON THE ACETABULAR SIDE DISLOCATED, AND THE CEMENTMOLD WAS REPLACED AGAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23027657 ↗
• 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 23025353 ↗
• MalfunctionSep 9, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT SCREWS WERE NOT LONG ENOUGH. LINER DID NOT SEAT PROPERLY, SO THE DR WANTED ANOTHER LINER. DOE: (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008548 ↗