Exactech 170-40-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862155580), received between Aug 4, 2023 and Nov 20, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REPLACEMENT AND HAD A THIRD REVISION SURGERY DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20733571 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REPLACEMENT AND HAD A SECOND REVISION SURGERY DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20733530 ↗
• InjuryFeb 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A FIRST RIGHT TOTAL HIP REVISION ON (B)(6) 2023 AND THEN APPROXIMATELY 7 MONTHS LATER EXPERIENCED A SECOND SURGICAL REVISION ON (B)(6) 2023. REVISION OPERATIVE REPORT OF (B)(6)2023: ASEPTIC LOOSENING OF ACETABULAR COMPONENT/ ACETABULAR PERIPROSTHETIC FRACTURE WITH PELVIC DISCONTINUITY/ SEVERE ACETABULAR BONE LOSS. REVISED TO COMPETITOR¿S DEVICES. THERE WAS SIGNIFICANT OSTEOLYSIS IN THE PROXIMAL FEMUR. THE ACETABULAR COMPONENT WAS GROSSLY LOOSE AND MIGRATED INTO THE PELVIS. LINER WAS REMOVED, THREE LOOSE SCREWS. THERE WAS SIGNIFICANT BONE LOSS IN THE ACETABULUM WITH SEVERE ILIUM AND PUBIC OSTEOLYSIS AS WELL AS ACETABULAR PERIPROSTHETIC FRACTURE INVOLVING THE ANTERIOR AND POSTERIOR COLUMN IN A TRUE PELVIC DISCONTINUITY MODE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER INFORMATION AVAILABLE. THE PATIENT HAD A PREVIOUS RIGHT HIP REVISION ON (B)(6) 2023 [MFR (B)(4) , WHERE THERE WAS EXTENSIVE OSTEOLYSIS OF THE PUBIS AND BONE LOSS NOTED. THE PERIPROSTHETIC FRACTURE NOTED AT (B)(6) 2023 SURGERY IS MOST LIKELY DUE TO THE EXTENSIVE OSTEOLYSIS/BONE LOSS THAT WAS NOTED IN THE ON (B)(6) 2023

  Patient problems: Osteolysis

  MAUDE report 18804373 ↗
• InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT HIP REVISION SURGERY ON (B)(6)2022. THEY SUBSEQUENTLY HAD A SECOND RIGHT HIP REVISION ON (B)(6) 2022, APPROXIMATELY 2 MONTHS AFTER THEIR PRECEDING REVISION. (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: DISLOCATION OF INTERNAL RIGHT HIP PROSTHESIS. THE SURGEON NOTED THERE WAS A SMALL EFFUSION. INSPECTION OF THE ABDUCTORS DID SHOW DELAMINATION FROM THE GREATER TROCHANTER APPROXIMATELY 75% WITH A SPLIT TEAR. THE FEMORAL HEAD WAS DISLOCATED. THE SURGEON FURTHER NOTED THAT THE RING WAS MOBILE AND THE IMPLANT WAS WELL FIXED TO THE CUP. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION; THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17458077 ↗

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-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,
• 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-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