PINNACLE 1218-40-664Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295012191), received between Dec 15, 2017 and Jan 27, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PRIOR REVISION, WITH A CONSTRAINED LINER PLACED. PATIENT FELL AND DISLOCATED. NEW CONSTRAINED LINER WAS PLACED WITH COMPETITOR HEAD. OLD LINER AND RING REMOVED AND NO FURTHER ISSUES. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24188665 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION AND DRAINAGE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANTATION: (B)(6) 2013; DATE OF REVISION #1: (B)(6) 2013; DATE OF REVISION #2:(B)(6) 2015; DATE OF REVISION #3: (B)(6) 2021; DATE OF REVISION #4: (B)(6) 2021; DATE OF EVENT: (B)(6) 2022; (LEFT HIP). TREATMENT: AWAITING REVISION.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 14699955 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTION: 1. FOLLOW-UP FOR WHICH APEX HOLE ELIMINATOR (PRODUCT DETAILS). A. ''YOU HAVE PROVIDED US TWO DIFFERING APEX HOLE ELIMINATORS. AS IT IS NOT POSSIBLE FOR THE PATIENT TO HAVE HAD TWO OF THEM IMPLANTED, WHICH ONE WAS IN PLACE AT THE TIME OF THIS REVISION? ANSWER: THE ORIGINAL APEX HOLE "ELIMINATOR" WAS PROBABLY DAMAGED OR STRIPPED SO A NEW ONE WAS REQUIRED ON (B)(6) 2013.

  Patient problems: Hematoma; Impaired Healing

  MAUDE report 12062940 ↗
• InjuryMar 31, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ON (B)(6) 2013, THE PATIENT RECEIVED A PRIMARY TOTAL HIP REPLACEMENT TO ADDRESS END-STAGE OSTEOARTHRITIS OF THE LEFT HIP. A DEPUY PINNACLE CUP S-ROM STEM CONSTRUCT WAS PLACED, WITH CERAMIC ON POLYETHYLENE ARTICULATION. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2013, PATIENT'S LEFT HIP WAS REVISED TO ADDRESS HIP RECURRENT INSTABILITY WITH MULTIPLE DISLOCATIONS. PATIENT INITIALLY DID WELL FOLLOWING PRIMARY, UNTIL HE SUSTAINED A TRAUMATIC FALL, WHICH LED TO A POSTERIOR DISLOCATION OF THE HIP. TWO ADDITIONAL DISLOCATIONS OCCURRED FOLLOWING THIS, WHILE PERFORMING FLEXION TYPE ACTIVITIES. THE PATIENT'S STEM AND CUP WERE DETERMINED TO BE WELL-FIXED, AND IN ADEQUATE POSITION/VERSION. CERAMIC HEAD SHOWED EVIDENCE OF METAL TRANSFER FROM THE MULTIPLE DISLOCATIONS. HEAD AND LINER WERE REVISED, WITH SELECTION OF A TEN DEGREE +4 LATERALIZED FACE CHANGING POLYETHYLENE ACETABULAR LINER, POSITIONED TO TWO O'CLOCK ORIENTATION. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2015, PATIENT RECEIVED A CLOSED REDUCTION OF THE LEFT DISLOCATED HIP WHILE UNDER ANESTHESIA. THERE WERE NO REPORTED COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. IT IS NOTEWORTHY THAT NO PRODUCTS WERE REVISED, AND THIS EVENT WITH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation

  MAUDE report 11594485 ↗
• InjuryMar 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PFS INDICATED THAT THE PATIENT HAD A DISLOCATION AND WAS TREATED WITH A CLOSED REDUCTION. NO REVISION INFORMATION WAS PROVIDED. DOI: (B)(6) 2006; DOE: (B)(6) 2016; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 8448259 ↗
• InjuryMar 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS LINER EXCHANGE FOR DISLOCATION. DOI: (B)(6) 2017 .DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7330228 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED HIP. DOI: (B)(6) 2017; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7203405 ↗
• InjuryDec 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7120640 ↗