Silicone PIP SPIP-520-2-WWRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556858516), received between Mar 16, 2023 and Mar 16, 2023 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K082231, K233670); 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.

• InjuryMar 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED APPROXIMATELY 2/3 YEARS AGO, THE PATIENT PRESENTED WITH PAIN AND INSTABILITY AND EXPERIENCED A BREAKAGE OF THE SILICONE PIP SZ. 1. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 16554513 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082231, K233670. 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