Ascension® Silicone PIP SPIP5202WWRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780116318), received between Nov 7, 2022 and Nov 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 other recall cover devices cleared under the same FDA submission (K082231); 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.

• MalfunctionNov 7, 2022Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem; Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A PIP ARTHROPLASTY, IT WAS NOTICED THAT WHEN ONE (1) SILICONE PIP SZ. 2 WAS OPENED FROM PACKAGING, THE IMPLANT WAS VISIBLY LARGER WITH THE WRONG SIZE, AND THERE WAS A MISMATCH BETWEEN PACKAGING AND IMPLANT SIZE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749363 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082231. One submission often covers many models, so check the product and lot details in each record.

• Z-0691-2020 · Nov 4, 2019 · Terminated
  Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal int