PINNACLE 1218-28-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295011460), received between Aug 17, 2018 and Dec 15, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED AS HEAD AND LINER EXCHANGE DUE TO DISLOCATION. HEAD SIZE WAS INCREASED FROM 28MM TO 40MM. OFFSET REMAINED THE SAME ON THE HEAD. LINER WAS SWAPPED OUT FOR A 40MM +4 10DEGREE X60. DOI: 2002; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11008103 ↗
• InjuryAug 17, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR. HEAD AND LINER REPLACEMENT. DOI: (B)(6) 2001; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7792604 ↗

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