NA 71354061Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556023280), received between Apr 5, 2018 and Mar 26, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K081124); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED AN INFECTION. EVENT WAS TREATED WITH MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 9884309 ↗
• InjuryMay 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION DEVELOPED TIME AFTER THE SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7489445 ↗
• InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO PAIN AND REDNESS AROUND OPERATIVE WOUND.

  Patient problems: Pain

  MAUDE report 7399230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081124. One submission often covers many models, so check the product and lot details in each record.

• Z-0945-2017 · Nov 15, 2016 · Terminated
  Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have
• Z-2427-2012 · Aug 22, 2012 · Terminated
  12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPH