Novation 132-32-53Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862023322), received between Dec 26, 2019 and Jul 26, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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

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.

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-2133-2021 · 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.

• InjuryJul 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT HIP REPLACEMENT ON (B)(6)2009. ON OR AROUND (B)(6)2023, RADIOLOGY STUDIES DEMONSTRATED POLYETHYLENE WEAR, BONE LOSS AND OSTEOLYSIS, IN THE SETTING OF RECALLED IMPLANTS, LEADING TO THE RECOMMENDATION FOR EXPLANTATION, WHICH IS TENTATIVELY PLANNED FOR THE FALL OF 2023. THE PATIENT HAS ADDITIONALLY SUFFERED BILATERAL HIP OSTEOLYSIS AND BONE LOSS AND WILL, UPON INFORMATION AND BELIEF, REQUIRE BILATERAL HIP PROSTHESES EXPLANTATION IN THE NEAR FUTURE. 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: Failure of Implant; Osteolysis

  MAUDE report 17401515 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2009. A LEFT HIP CT AND X-RAY SHOWED A TREMENDOUS AMOUNT OF OSTEOLYSIS. THE SURGEON REVISED THE (B)(6) MALE¿S LINER TO AN E-POLY AND REPLACED THE HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ALL AVAILABLE INFORMATION RECEIVED AT THIS TIME.

  Patient problems: Osteolysis

  MAUDE report 9519564 ↗