PINNACLE 1218-32-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295011545), received between May 24, 2021 and Jul 3, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THE PATIENT ORIGINALLY HAD A PINNACLE CUP AND SROM STEM IMPLANTED APPROXIMATELY THIRTY (30) YEARS AGO. AFTER THE PATIENT EXPERIENCED TRAUMA, THE FEMORAL HEAD BROKE THROUGH THE CUP/LINER AND THE PATIENT UNDERWENT AN ACETABULAR REVISION. THE SURGEON NOTED, THAT PREVIOUS UNTREATED TRAUMA AND OTHER COMORBIDITIES CONTRIBUTED TO THE DAMAGE TO THE HIP AND NEED FOR THE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 22394181 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HCP IS REPORTING TO BFARM/NCA: "REVISION SURGERY OF THE RIGHT HIP JOINT WITH CUP REPLACEMENT ON (B)(6) 2023 BECAUSE DISLOCATION OF THE PE INLAY FROM THE METAL CUP WITH CONSECUTIVE CONTACT OF THE CERAMIC HEAD WITH THE METAL CUP." DOI: SEP 2011, DOR: ON (B)(6) 2023, RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16680931 ↗
• InjuryOct 10, 2022Naturally Worn; Naturally Worn

  REVISION COMPLETED TO ADDRESS DISCOMFORT, OSTEOLYSIS, AND POLYETHYLENE BEARING WEAR. HEAD AND LINER WERE REVISED. DOR: (B)(6) 2022.

  Patient problems: Discomfort; Osteolysis

  MAUDE report 15568852 ↗
• InjuryOct 10, 2022Naturally Worn; Naturally Worn

  REVISION COMPLETED TO ADDRESS DISCOMFORT, OSTEOLYSIS, AND POLYETHYLENE BEARING WEAR. HEAD AND LINER WERE REVISED. DOR: (B)(6) 2022.

  Patient problems: Discomfort; Osteolysis

  MAUDE report 15568834 ↗
• InjuryJun 22, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE PINNACLE A (OTHER COMPANY¿S DEVICE) AND THE SROMA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT FELL OFF, AND THE FRACTURE OF THE FEMORAL STEM OCCURRED. THE LINER WAS WORN OUT, AND OSTEOARTHRITIS WAS FOUND. THEREFORE, THE SURGEON DECIDED TO LEAVE THE CUP AND THE SLEEVE AND PLANNED TO FIX THE FRACTURE WITH CABLES. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. IN THE REVISION SURGERY, IT WAS CONFIRMED THAT THERE WERE BLACK CORROSIONS ON THE METAL HEAD AND THE STEM. THE SURGEON REPLACED THE LINER, THE HEAD (DELTA), AND THE STEM WITH NEW IMPLANTS. NEXT, THE SURGEON USED CABLES (THE OTHER COMPANY¿S DEVICES) TO REINFORCE THE FRACTURE SITE. DOI: (B)(6) 2009. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Fall

  MAUDE report 14773738 ↗
• InjuryFeb 28, 2022Naturally Worn; Naturally Worn

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN. PATIENT WAS ASYMPTOMATIC FOLLOWING HIP SURGERY UNTIL PATIENT SUFFERED A FALL. AMBULATION QUALITY AND DISTANCE DECREASED. PATIENT COMPLAINED OF PAIN DURING ACTIVITY AND AT REST. RADIOLOGY REVEALED LARGE OSTEOLYSES IN TROCHANTER MAJOR AND MINOR AND POLY WEAR. IN CONJUNCTION WITH THE RADIOLOGICAL FINDINGS INDICATION FOR INLAY REPLACEMENT SURGERY WAS GIVEN. DOI: (B)(6) 2007; DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Fall; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 13619911 ↗
• InjuryMay 24, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2005, THE PATIENT UNDERWENT THE SURGERY VIA LEFT ¿ THA WITH THE IMPLANTS. ON (B)(6) 2007, THE PATIENT UNDERWENT THE SURGERY VIA RIGHT ¿ THA WITH THE IMPLANTS. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY TO BOTH HIPS BECAUSE OF POLYETHYLENE LINER WEAR. AT THAT TIME, THE SURGEON USED ANOTHER COMPANY'S CUP. THE SURGEON COMMENTED THAT THE POLYETHYLENE LINERS WERE WORN OUT DUE TO AGING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11870792 ↗