Exactech 148-32-93Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862027887), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K050398, K060107); 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 16, 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.

• InjuryMar 21, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 72 YO MALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2010, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 12 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE DR.¿S OFFICE COMPLAINING ABOUT PAIN AND DISSATISFACTION OF THEIR RIGHT PRIMARY HIP. UPON EXAMINATION AND IMAGING, THE POLY SHOWED TO BE WORN AND HAD LYSIS BEHIND THE IMPLANT. THE HEAD AND POLY LINER WERE SWAPPED. BONE SUBSTITUTE WAS PLACED BEHIND THE CUP IMPLANT TO FILL BONE VOIDS AND A NEW VITAMIN E-LIPPED LINER AND A 36MM HEAD WERE RE-IMPLANTED. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES AVAILABLE FOR RETURN. THE IMPLANTS ARE SENT TO THE LAB AND LEGAL AND ARE NOT GIVEN TO THE REPRESENTATIVE. NO FURTHER INFORMATION.

  Patient problems: Osteolysis; Pain

  MAUDE report 16588298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050398, K060107. One submission often covers many models, so check the product and lot details in each record.

• Z-2251-2021 · Jun 29, 2021 · Completed
  Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
• Z-2250-2021 · Jun 29, 2021 · Completed
  Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.