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MP Monoblock - Instruments 136-202/01Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Orthopaedic prosthesis instrument, reusable - General Instrument · Class 1

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026575181995), received between Aug 9, 2023 and Aug 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (3 reports).

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

  • Difficult or Delayed Separation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

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

  • MalfunctionAug 10, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

    PROBLEMS WERE ENCOUNTERED WHEN REMOVING THE TRIAL (195 X 16 MM WITH LATERALIZED TRIAL BODY): HE HAD TO ADD THE EXTRA IMPACTION AND IT TOOK A LOT OF HITS TO REMOVE THE TRIAL. WITH THE FORCE HE USED, IT MADE IT NEAR IMPOSSIBLE TO CATCH THE TRIAL ONCE IT DID COME OUT, AND UNFORTUNATELY THE WHOLE TRIAL HIT THE FLOOR. WITH HIS ORIGINAL TRIAL BEING CONTAMINATED, WE HAD TO TRIAL WITH THE 195X15 AND THE STANDARD NECK- NOT EXACTLY A GREAT WAY TO CHECK FOR AN ACCURATE FIT. THIS ENDED UP IMPEDING THE CASE AS WE HAD TO X-RAY WITH THE REAL IMPLANT, AND HAD TO THEN REMOVE THE REAL IMPLANT TO RE-REAM AFTER SEEING THE SCANS. OVERALL WAS HAPPY WITH THE OUTCOME FOR THE PATIENT, BUT IT COULD HAVE GONE SMOOTHER WITH BETTER INSTRUMENTATION. [CUSTOMER]

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17496585 ↗
  • MalfunctionAug 9, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

    PROBLEMS WHEN REMOVING THE TRIAL STEM. [CUSTOMER].

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17487365 ↗
  • MalfunctionAug 9, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

    PROBLEMS WHEN REMOVING THE TRIAL STEM. [CUSTOMER].

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17486439 ↗

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Sources and updates

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