PINNACLE 1218-28-458Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295011453), received between Aug 9, 2021 and Aug 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000306, K001534); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED DUE TO POLY WEAR AND INSTABILITY. THE PATIENT'S PRIMARY 28MM FEMORAL HEAD AND PINNACLE POLYETHYLENE LINER WERE REMOVED AND REPLACED BY A 40MM BIOLOX DELTA TS CERAMIC REVISION FEMORAL HEAD AND A PINNACLE ALTRX POLYETHYLENE LINER. DOI: (B)(6) 2003, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12298138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000306, K001534. One submission often covers many models, so check the product and lot details in each record.

• Z-0569-2013 · Nov 28, 2012 · Terminated
  Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed i