MAUDE Adverse Event Report: NOVOSOURCE, LLC NOVOHIP TOTAL HIP SYSTEM; HIP PROSTHESIS

Model Number	1345-2803
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530)
Type of Reportable Event	Malfunction
Event or Problem Description
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 recur, it would likely cause or contribute to serious injury.

• Brand Name: NOVOHIP TOTAL HIP SYSTEM
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): NOVOSOURCE, LLC; 1000 hampton center; suite a; morgantown WV 26505
• Manufacturer (Section G): NOVOSOURCE, LLC; 1000 hampton center; suite a; morgantown WV 26505
• Manufacturer Contact: jessica singelais ; 1000 hampton center; suite a; morgantown, WV 26505 ; 3045542167
• MDR Report Key: 20412105
• Report Number: 3014273644-2024-00002
• Device Sequence Number: 7969682
• Product Code: LPH
• UDI-Device Identifier: 00811382037818
• UDI-Public: 00811382037818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1345-2803
• Device Catalogue Number: 1345-2803
• Device Lot Number: CER0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3014273644/09232024/C/00
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male