NovoHip Total Hip SystemRecalls & reported problems across all models

We found 2 models of NovoHip Total Hip System by Novosource, LLC in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2024 and Oct 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (2 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

NovoHip Total Hip System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 19, 2024Open, 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 NovoHip Total Hip System problems

NovoHip Total Hip System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NovoHip Total Hip System 1345-3203

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 recall1 report
• NovoHip Total Hip System 1345-2803

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report

Recent NovoHip Total Hip System adverse event reports

The 2 most recent reports across all models, 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 ↗
• 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 ↗