NA 01-003-10-0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862267146), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K140674, K162732, K182462); 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.

• InjurySep 17, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED, DURING A HIP REVISION ON (B)(6) Y/O MALE PATIENT¿S LEFT THA 8 YRS POSTOP, THE SURGEON BEGAN THREADING THE EXTRACTION TOOL TO THE FEMUR AND IT WOULD NOT SEAT FULLY. HE SAID HE DID TO THE BEST HE COULD WITH CLEANING OUT THE EXISTING TISSUE. IT WAS MENTIONED THAT WITH THE EXTRACTION DEVICE NOT BEING FULLY SEATED, HE NEEDS TO BE CAREFULLY. HE ATTACHED THE SLAP HAMMER AND MADE MULTIPLE ATTEMPTS TO TEST AND SEE IF THE FEMUR WOULD COME OUT. AFTER HIS FIFTH OR SIXTH TIME, THE THREADED EXTRACTION TIP BROKE OFF AND REMAINED THREADED INTO THE STEM. HE THEN ATTEMPTED TO REMOVE THE STEM WITH THE TRUNNION EXTRACTION INSTRUMENT ATTACHED TO THE SLAP HAMMER. AFTER NUMEROUS ATTEMPTS THE SURGEON STATED, "AT LEAST I TRIED TO REMOVE IT". REMOVAL OF THE STEM WAS NOT DISCUSSED, ONLY TRYING TO TEST STABILITY. THE SURGEON LEFT THE STEM AND SWAPPED OUT THE FEMORAL HEAD WITH A NEW HEAD AND COLLAR. THE BROKEN THREADED TIP REMAINED IN THE PATIENT AND SURGEON DID NOT APPEAR CONCERNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. . BROKEN KNEE INSTRUMENT TO BE RETUNED. KNEE INSTRUMENT TO BE RETUNED UNDER (B)(4). THIS CASE WILL CAPTURE THE MALFUNCTION AND THE REVISION WILL BE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10549722 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140674, K162732, K182462. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2018 · Oct 9, 2017 · Terminated
  Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals underg