NovoHip Total Hip System 1345-3203Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811382037849), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 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 18, 2026.

Recalls naming this device

1. Sep 19, 2024Class IIOpen, Classified

   Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted

   Z-0483-2025 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

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 16, 2024Wrong Label; Wrong Label

  A COMPLAINT WAS RECEIVED ON SEPTEMBER 12, 2024 (RELATED REPORT: MDR 3014273644-2024-00002) 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 (B)(4) 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. ON SEPTEMBER 19, 2024, UPON INSPECTION OF RETURNED UNITS, NOVOSOURCE BECAME AWARE THAT A LOT QUANTITY OF (B)(4) 28 L CERAMIC HEADS WERE PACKAGED WITH LABELING THAT INDICATED SIZE 32 L. THUS, THE DECISION WAS MADE THAT A FIRM-INITIATED RECALL WAS APPROPRIATE AND THE APPROPRIATE FDA DIVISION RECALL COORDINATOR WAS NOTIFIED WITHOUT DELAY. INFORMATION OBTAINED THROUGH A HEALTH HAZA

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

  MAUDE report 20466582 ↗