Morse Head 01-2200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327016086), received between Mar 13, 2020 and Jun 18, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K910988, K993601); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 1998 THE FEMALE PATIENT WAS INITIALLY INSERTED THA CUP, WHICH WAS REVISED ON (B)(6) 2020. IT WAS PLANNED TO REPLACE FROM THE LINER OF 22 MM DIAMETER TO THE LINER OF 32 MM DIAMETER AFTER REMOVING THE NECK. BUT THE NECK COULD NOT BE REMOVED, AND IT REMAINED AS IT WAS, AND CLOSED AT THAT TIME. AFTER THAT, SHE BEGAN TO DISLOCATE MORE FREQUENTLY, AND ON (B)(6) 2020, THE STEM SIDE WAS ALSO PREPARED IN CONSIDERATION OF THE POSSIBILITY THAT THE NECK WON¿T BE COME OUT. THE CONDITION OF THE FEMUR BONE WAS ALSO GOOD, AND THE SURGEON WANTED TO REMOVE THE NECK AS MUCH AS POSSIBLE AND ONLY REPLACE THE NECK AND LINER BECAUSE THE STEM IS FIRMLY FIXED. BUT DESPITE THE FACT THAT THE SURGEON WAS CAREFULLY PREPARING FOR THE REMOVAL OF THE NECK, AFTER ALL, THE FEMUR COULD NOT BE PULLED OUT, AND THE FEMUR WAS VERTICALLY SPLIT AND THE STEM WAS REMOVED, AND A NEW STEM, NECK 32 MM, AND LINER WERE REPLACED. INITIALLY, IT WAS PLANNED TO BE LESS THAN 1-HOUR OP IF THE NECK GOT OUT, BUT FINALLY IT TOOK 5 HOURS. THE SURGEON REQUESTED TO INVESTIGATE THE REASON; WHY HE COULD NOT REMOVE THE PRODUCT. HE HAD NEVER EXPERIENCED A CASE WHERE THE NECK COULD NOT COME OUT SO DIFFICULT AND TOOK SO LONG. ORIGINALLY

  Patient problems: Blood Loss; Injury; Joint Dislocation

  MAUDE report 10170740 ↗
• InjuryMar 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT BIPOLAR HIP ARTHROPLASTY IN 1996. THE BIPOLAR CUP WAS BROKEN, AND DISLOCATION OCCURRED. THEREFORE, THE BIPOLAR CUP AND THE INNER HEAD WERE REMOVED AND THA WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9828617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K910988, K993601. One submission often covers many models, so check the product and lot details in each record.

• Z-0390-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
• Z-0391-2010 · Sep 4, 2009 · Terminated
  Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
• Z-1822-2009 · Jun 18, 2009 · Terminated
  V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended f