Novation 136-40-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862220301), received between May 6, 2022 and Apr 28, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

5 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 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-1732-2022 · 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-2129-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

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.

• InjuryApr 28, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A HIP REPLACEMENT ON (B)(6) 2020. APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A HIP REVISION ON (B)(6) 2021. 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: Insufficient Information; Pain

  MAUDE report 16834147 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY ONE MONTH POST INITIAL LEFT SIDE THA, PATIENT HAD A REVISION FOR AN UNKNOWN REASON. THE REPRESENTATIVE HAS NO KNOWLEDGE OF THIS CASE FROM 2016. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15834121 ↗
• InjuryJun 9, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, PATIENT HAD A LEFT HIP REVISION DUE TO LOOSENING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR'S DEVICE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 14644059 ↗
• InjuryMay 6, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL LEFT THA, THE (B)(6) MALE PATIENT HAD A REVISION DUE TO LOTS OF WEAR ON POLY AND PATIENT HAD METALLOSIS ALL OVER HIS HIP. THERE WAS NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS A 45 MINUTES SURGICAL DELAYED BUT THERE WAS NO ADVERSE EVENT AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. PATIENT WAS REVISED TO XLE POLY. SALES REP WAS UNABLE TO OBTAIN X-RAYS/PHOTOS. THE DEVICE WILL BE RETURN.

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

  MAUDE report 14308039 ↗

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-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-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-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-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,