Exactech 170-40-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862155504), received between Sep 16, 2024 and Feb 19, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K121392); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT, THE PATIENT UNDERWENT LEFT HIP REVISION TO ADDRESS PROSTHESIS WEAR. A POST OPERATIVE OP REPORT WAS PROVIDED. POST OP DIAGNOSIS NOTED CHRONICALLY FAILED TOTAL HIP ARTHROPLASTY DUE TO POLYETHYLENE WEAR. INTRAOPERATIVELY, THE SURGEON OBSERVED METALLOSIS AND SYNOVITIS AND FRAGMENTED POLYETHYLENE LINER PIECES IN THE JOINT CAUSING THE METALLOSIS. ADDITIONALLY, THE SURGEON OBSERVED A LINEAR SCRATCH ON THE SURFACE OF THE FEMORAL HEAD. BOTH LINER AND FEMORAL HEAD COMPONENTS WERE REPLACED. IT WAS NOTED THAT THE PATIENT'S WEIGHT CONTRIBUTED TO A MORE COMPLEX APPROACH AND POSITIONING DIFFICULTIES, INTRAOPERATIVELY. NO SURGICAL OR THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Bone Shedding Debris; Failure of Implant; Metal Related Pathology; Scar Tissue; Synovitis

  MAUDE report 21411605 ↗
• InjurySep 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 59 Y/O MALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 5 YEARS POST OP. THE PATIENT RETURNED TO SURGEONS OFFICE COMPLAINING OF PAIN, SWELLING, AND DISSATISFACTION WITH THEIR LEFT PRIMARY TOTAL HIP. THE POLY AND A RECALLED IMPLANT WERE IN QUESTION AND SHOWN TO BE WORN ON X-RAY. THE PATIENT UNDERWENT AN ACETABULAR POLY IMPLANT AND A FEMORAL HEAD SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: IMPLANTS ARE SENT TO THE LAB AND LEGAL.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20233178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121392. One submission often covers many models, so check the product and lot details in each record.

• Z-1732-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL,
• Z-2129-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant
• Z-2123-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40
• Z-2118-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
• Z-2133-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,
• Z-2119-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component
• Z-2117-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral,