PINNACLE 1219-36-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295014614), received between Oct 19, 2017 and Aug 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS PERSISTENT COMPLICATIONS FOLLOWING HIP PROSTHESIS SURGERIES. PATIENT UNDERWENT INITIAL HIP REPLACEMENT IN 2019, WHICH CONSISTENTLY CAUSED ISSUES. FROM THE MOMENT OF THE OPERATION, THE PATIENT COMPLAINED OF A MEASUREMENT ISSUE; HIS OPERATED LEG WAS 2 CM LONGER. AFTER 4 YEARS OF PAIN AND MULTIPLE VISITS TO THE SURGEON, THE PATIENT DECIDED TO CONSULT ANOTHER SURGEON. AFTER SEVERAL EXAMINATIONS, A REVISION WAS DECIDED. IN (B)(6) 2023, THE LOOSENED PROSTHESIS WAS REMOVED AND A SPACER WAS PLACED DUE TO SUSPECTED INFECTION. A NEW PROSTHESIS WAS IMPLANTED IN (B)(6) 2023, BUT PAIN AND FLUID BUILDUP PERSIST. MULTIPLE TESTS (PUNCTURES, CLEAN-UP SURGERY, ARTHROSCOPY) HAVE RETURNED NEGATIVE RESULTS. REFERRED TO THE HOSPITAL, WHERE ALLERGY IS NOW BEING CONSIDERED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Physical Asymmetry; Swelling/ Edema; Unspecified Infection

  MAUDE report 22911244 ↗
• InjuryApr 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON REPORTED DISLOCATION OF GRIPTION CUP. A REVISION OF CUP IS PLANNED. DOI: (B)(6) 2018. DOI: (B)(6) 2018; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7395701 ↗
• InjuryOct 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: SEP 22, 2017: PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS STATED THAT AFTER PATIENT'S 1ST REVISION (B)(6) 2008), PATIENT HAD EXPERIENCED PAIN AND TROCHANTERIC BURSITIS. THERE IS NO 2ND REVISION REPORTED AT THIS TIME. UPDATE SEP 22, 2017 REVIEWED RECORDS FOR REPORTABILITY. IDENTIFIED THAT DURING REVISION SURGERY (B)(6) 2008, SURGEON EXPLANTED S-ROM STEM (LEAVING THE S-ROM SLEEVE) AND REPLACED IT WITH ANOTHER STEM. THERE IS NO RECORD OF THIS NEW STEM ON THE IMPLANT RECORD FOR (B)(6) 2008, BUT IT IS CLEARLY NOTED IN THE OR REVISION OPERATIVE NOTE. ADDED AN UNKNOWN S-ROM STEM FOR ALLEGED PAIN. COMPLAINT UPDATED ON: OCT 20, 2017 / / INVESTIGATION METHOD: / / INVESTIGATION SUMMARY:

  Patient problems: Inflammation; Pain; Tissue Damage

  MAUDE report 6964008 ↗