Novation 136-32-54Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862024305), received between Sep 26, 2023 and Mar 26, 2024 — classified as 2 injuries.

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

2 FDA recall records name this device's identifier, 2 still open.

14 other recalls cover devices cleared under the same FDA submission (K070479); 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 18, 2026.

Recalls naming this device

1. Aug 11, 2022Class IIOpen, Classified

   Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

   Z-1729-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 29, 2021Class IIOpen, Classified

   Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

   Z-2127-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

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.

• InjuryMar 26, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A HIP PROSTHETIC SOCKET FROM EXACTECH IN 2019. A PERIPROSTHETIC ACETABULAR FRACTURE WAS DIAGNOSED IN (B)(6) 2023 AS A RESULT OF A BICYCLE FALL. IN THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD AND AN UNUSUALLY LARGE ONE OSTEOLYSIS IN THE FRACTURED ACETABULUM AREA AS A SIGN OF INLAY WEAR. FIRST THERE WAS ONE CONSERVATIVE TREATMENT OF THE FRACTURE. THE INLAY WEAR COULD THEN BE SEEN DURING A REVISION OPERATION ON (B)(6) 2024. INLAY CHANGE TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, NEUTRAL LINER, GROUP 4, 36 MM I.D., REF 104-36-54 SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, THE INLAY WAS ALSO REPLACED THE DETERMINATION OF THE SOLID CUP INTEGRITY AS WELL AS THE CURETTAGE AND SEALING OF THE CYSTS IN THE CUP BED USING ALLOGENEIC SPONGIOSA AND CHANGING THE PROSTHETIC HEAD.

  Patient problems: Bone Fracture(s); Bruise/Contusion; Insufficient Information; Osteolysis

  MAUDE report 18983877 ↗
• InjurySep 26, 2023Naturally Worn; Naturally Worn

  THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM AS A SIGN OF INLAY WEAR. REVISION ON (B)(6) 2024.

  Patient problems: Cyst(s); Osteolysis; Pain

  MAUDE report 17816558 ↗

Recalls under the same FDA submission

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

• Z-2132-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL a
• 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-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-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-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-2128-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. 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-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-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-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-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-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-0787-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replaceme
• Z-0788-2013 · Nov 5, 2012 · Terminated
  Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip r