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INSTRUMENT 1150-2600Recalls & reported problems

Howmedica Osteonics Corp. · UNI ADAPTOR SLEEVE · Class 1

All models of INSTRUMENT (131)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327238587), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 injury.

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

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

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryApr 28, 2023Fracture; Fracture

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY DURING THE (B)(6) 2020, SURGERY THE UNI ADAPTER SLEEVE WAS INADVERTENTLY LEFT IN THE PATIENT'S ACETABULUM AND WAS IDENTIFIED ON A POST OP X-RAY. IT IS FURTHER ALLEGED THAT, AS A RESULT OF THIS FOREIGN BODY BEING LEFT IN THE HIP, THE PATIENT WAS FORCED TO UNDERGO AN ADDITIONAL SURGERY ON (B)(6) 2020, TO REMOVE IT. UPON REMOVAL, ONE OF THE PRONGS ON THE UNI ADAPTER SLEEVE WAS REPORTED AS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16839098 ↗

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Sources and updates

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