Description of Event or Problem · 0
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 HAZARD EVALUATION SUPPORTED THAT IF THE MALFUNCTION WERE TO RECUR, IT WOULD LIKELY CAUSE OR CONTRIBUTE TO SERIOUS INJURY.