NA 121-01-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862020376), received between Aug 19, 2021 and Jun 17, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

24 other recalls cover devices cleared under the same FDA submission (K070479, K071676, K100269, K182502); 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.

• InjuryJun 17, 2022Break; Break

  IT WAS REPORTED THAT WHILE PERFORMING A THA SURGICAL PROCEDURE, DURING FINAL IMPACTION FOR THE CROWN CUP, IT LOOKS THAT A TIP OF HANDLE WAS BROKEN. THERE WAS NO IMPACT FOR THE INSTALLATION OF THE CUP BECAUSE THIS HAPPENED DURING THE FINAL STEP. PARTS AND PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND. THE SURGEON REMOVED THE PARTS/PIECES FROM THE PATIENT. THERE WAS NO SURGICAL DELAY/PROLONGATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739026 ↗
• MalfunctionApr 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED FROM JAPAN THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON EXPERIENCED ISSUES WITH THE OFFSET CUP IMPACTOR. THE CLUSTER HOLDS IMPLANT, 48MM, THE DEVICE WAS ATTACHED AND IMPACTED. AFTER IMPACTION, THE SURGEON COULD NOT REMOVE THE OFFSET CUP IMPACTOR IN QUESTION SMOOTHLY FROM THE IMPLANT BECAUSE THE RELEASE LEVER ¿WAS TOO HARD UNDER USUAL STRENGTH¿. ¿SO, THE DOCTOR TRIED SEVERAL TIMES AND FINALLY HE PUT ALL HIS STRENGTH INTO HIS ARM, NOT LIKE THE USUAL WAY. HE WAS ABLE TO REMOVE IT FROM THE IMPLANT, BUT THE SCREW AND SPRING FALL OFF AT THE SAME TIME. THE CAUSE AND EFFECT ARE UNCERTAIN. ALL PIECES WERE ACCOUNTED FOR AND THIS DID NOT DELAY SURGERY. THE PATIENT¿S HEALTH WAS STABLE LEAVING THE OPERATING ROOM.¿ THE REPRESENTATIVE WAS PRESENT AT THE TIME OF SURGERY. NO PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135864 ↗
• MalfunctionAug 19, 2021Break; Break

  WHEN WE WERE IMPACTING THE LINER IMPLANT, THE DISTAL PORTION OF THE IMPACTOR CHIPPED OFF AND BROKE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342245 ↗
• MalfunctionAug 19, 2021Break; Break

  THIS IMPACTOR HANDLE BROKE WHEN IMPACTING THE FINAL LINER. THIS IS THE SECOND TIME TODAY THIS HAPPENED IN TWO SEPARATE CASES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342208 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070479, K071676, K100269, K182502. One submission often covers many models, so check the product and lot details in each record.

• Z-1167-2025 · Dec 31, 2024 · Open, Classified
  Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G22
• Z-0581-2024 · Nov 21, 2023 · Open, Classified
  Exactech Novation Hip System, Catalog Numbers: 134-36-45
• Z-0578-2024 · Nov 21, 2023 · Open, Classified
  Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
• Z-1730-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32M
• Z-1729-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUT
• Z-1731-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. N
• Z-2121-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID;
• Z-2131-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Line
• Z-2120-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant
• Z-2116-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28m
• Z-2122-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped A
• Z-2126-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner,
• 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-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-2115-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant co

…and 9 more.