NA 01-003-02-0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862267122), received between Jan 13, 2021 and Jul 22, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2022Break; Break

  IT WAS REPORTED THAT THE CUP IMPACTOR BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087744 ↗
• MalfunctionJul 22, 2022Break; Break

  IT WAS REPORTED THAT THE STRIKE PLATE ATTACHED TO THE BROACH HANDLE BROKE OFF WHEN TRYING TO BACK SLAP THE BROACH AND HANDLE OUT OF THE PATIENT. THE 2ND ONE IN A MONTH, HE HAS HAD BROKEN. NO PARTS OR PIECES FELL INTO THE WOUND. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087628 ↗
• MalfunctionMay 4, 2021Break; Break

  AS REPORTED, DURING A PROCEDURE ON A (B)(6) Y/O MALE PATIENT, THE SURGEON WAS BROACHING THE CANAL WITH COMPACTION BROACHES FOR THE ALTEON HA. HE BROACHED TO A SIZE 10 AND WAS UNABLE TO REMOVE THE BROACH. REMOVAL OF THE BROACH FROM THE FEMORAL CANAL TOOK PLACE OVER AN APPROX 10 MINUTE TIME FRAME WITH NO REPORTED EFFECTS TO THE PATIENT. THE BROACH HANDLE STRIKE PLATE BROKE FREE FROM THE BROACH HANDLE. ANOTHER BROACH HANDLE WAS ATTACHED AND EVENTUALLY THE SURGEON WAS ABLE TO REMOVE THE BROACH. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769872 ↗
• MalfunctionMar 22, 2021Break; Break

  AS REPORTED, THE BROACH HANDLE CAME APART WHILE IMPACTING DURING A CASE. NOTHING WAS LEFT IN THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543816 ↗
• MalfunctionJan 13, 2021Break; Break

  AS REPORTED, THE BROACH HANDLE WAS BEING USED IN SURGERY AND A PIECE BROKE OFF WHILE IN USE. IT DID NOT AFFECT THE SURGERY, WE JUST USED THE OTHER BROACH HANDLE. THERE WERE NO PIECES THAT FELL INTO THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11163333 ↗

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