Exactech 170-28-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862155559), received between Jul 21, 2023 and Jul 11, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 7 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19719212 ↗
• InjuryJul 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 7 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19719134 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2023 AND THEN WAS REVISED AGAIN ON (B)(6) 2023 ONE MONTH LATER FOR INFECTION. THE PATIENT WAS ADMITTED ON (B)(6) 2023 TO FOR INFECTION IN HIS LEFT HIP. PRE-OP DIAGNOSIS- INFECTION OF PROSTHETIC HIP JOINT. WOUND CLASSIFICATION: DIRTY- OLD TRAUMATIC WOUNDS WITH RETAINED DEVITALIZED TISSUE AND THOSE THAT INVOLVE EXISTING CLINICAL INFECTION OR PERFORATED VISCERA. THIS DEFINITION SUGGESTS THAT THE ORGANISMS CAUSING POSTOPERATIVE INFECTION WERE PRESENT IN THE OPERATIVE FIELD BEFORE THE OPERATION. INTRAOPERATIVE FINDINGS: MAINLY SUPERFICIAL FLUID COLLECTION AND EDEMA ABOUT IT. SOME RATTY TISSUE DEEP AROUND CAPSULE BUT NO DEEP PURULENCE. PROCEDURE: DISENGAGED HEAD AND LINER. STEM AND REVISION CUP WERE WELL FIXED. NO LOOSE SCREWS. PATIENT WAS SENT TO PACU IN STABLE CONDITION. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18453151 ↗
• InjuryJul 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, HAD A RIGHT HIP ARTHROPLASTY REVISION ON (B)(6), 2017 AND THEN WHAT IS REPORTED AS RE REVISION ON AN UNKNOWN DATE. THE PATIENT COMPLAINS OF PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE AND NECESSITATED REVISION SURGERIES AND THE RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY. THE PATIENT¿S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN CONSEQUENTLY LIMITED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 17371905 ↗