NovoHip Total Hip System 1345-2803Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811382037818), received between Oct 9, 2024 and Oct 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Wrong Label” (1 report).

1 other recall cover devices cleared under the same FDA submission (K132158); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Wrong Label; Wrong Label

  AN INITIAL COMPLAINT WAS RECEIVED ON SEPTEMBER 12, 2024, INDICATING THAT IT WAS DISCOVERED INTRAOPERATIVELY THAT A BOX LABELED AS CONTAINING A SIZE 28 L CERAMIC HEAD ACTUALLY CONTAINED A SIZE 32 L CERAMIC HEAD (CORRECT SIZE DIRECTLY MARKED ON THE DEVICE). NO PATIENT INJURY OR DEATH WAS REPORTED. NOVOSOURCE BECAME AWARE THAT BIOLOX CERAMIC HEADS, A COMPONENT IN THE NOVOSOURCE TOTAL HIP SYSTEM HAD BEEN MISLABELED. SIZES 28 L AND 32 L HAD SEEMINGLY BEEN REVERSED. THE PRELIMINARY INVESTIGATION INDICATED THAT THE ISSUE WAS RESTRICTED TO 2 LOTS, EACH CONTAINING A QUANTITY OF 10 UNITS. AS PART OF THE ONGOING COMPLAINT INVESTIGATION AND CONTAINMENT ACTIONS, THE SUSPECT LOT AND THE ASSOCIATED LOT (PACKAGING LABELED AS SIZE 32 L HEADS) WERE REQUESTED TO BE RETURNED FOR EVALUATION. UPON INSPECTION OF THE RETURNED UNITS, NOVOSOURCE IS AWARE THAT THE 28 L CERAMIC HEADS WERE INDEED ALSO PACKAGED WITH LABELING THAT INDICATED SIZE 32 L. THUS, THE DECISION WAS BEEN MADE THAT A FIRM-INITIATED RECALL WAS APPROPRIATE AND THE APPROPRIATE FDA DIVISION RECALL COORDINATOR WAS NOTIFIED WITHOUT DELAY. FINALLY, INFORMATION OBTAINED THROUGH A HEALTH HAZARD EVALUATION SUPPORTED THAT IF THE MALFUNCTION WERE TO

  Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology; Osteolysis

  MAUDE report 20412105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132158. One submission often covers many models, so check the product and lot details in each record.

• Z-0483-2025 · Sep 19, 2024 · Open, Classified
  NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement