PINNACLE 1219-28-256Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295013648), received between Mar 12, 2019 and Apr 12, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Naturally Worn; Naturally Worn

  REVISION OF PINNACLE INSERT AND HEAD EXCHANGE. PATIENT UNDERWENT REVISION DUE TO WEAR OF THE POLY. NO INFECTION SEEN.

  Patient problems: Insufficient Information

  MAUDE report 19100603 ↗
• InjurySep 1, 2022Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL HIP TO ADDRESS LINER POLYETHYLENE WEAR. DATE OF IMPLANTATION: (B)(6) 2002; DATE OF REVISION: (B)(6) 2022; (LEFT HIP). TREATMENT: FEMORAL HEAD AND ACETABULAR LINER WERE REVISED.

  Patient problems: Foreign Body Reaction; Insufficient Information; Joint Laxity; Pain

  MAUDE report 15341257 ↗
• InjuryJun 12, 2020Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  SURGEON REPORTED TO BFARM: "INCREASING PAIN IN THE RIGHT HIP WITHOUT TRAUMA AFTER GETTING UP AND AUDIBLE CRACKING; PREOPERATIVE RADIOLOGICAL: CERAMIC HEAD FRACTURE AFTER HIP TEP 15 YEARS AGO; INTRAOPERATIVELY: THE MOST LIKELY OLDER EVENT WITH FRAGMENTS THAT ARE FIRMLY ENCAPSULATED IN THE CAPSULE / SCAR TISSUE, SOME FRESHLY LYING IN THE JOINT."

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 10146951 ↗
• InjuryMar 12, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON REMOVED THE PARTS LISTED BELOW AND REPLACED WITH AN MDM CUP CONSTRUCT AND DEPUY FEMORAL HEAD. REASON FOR REVISION WAS POLY WEAR. NO OTHER INFORMATION IS KNOWN OR AVAILABLE TO DEPUY AT THIS TIME. TO ANSWER QUESTION BELOW, NO INSTRUMENTS WERE BROKEN. THEREFOR, NOTHING RETRIEVED. DOI: (B)(6) 2007; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8413010 ↗