MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG ANA.NOVA II CE INSERT 48 DIA 36 DELTA; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75008438

Device Problem Break (1069)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 09/22/2020

Event Type  Injury  

Event Description

It was reported that, after a tha in which an artiqo shell, smith & nephew stem and biolox delta ceramic bearings had been implanted on the right hip, the ceramic bearings broke.A revision surgery was performed on (b)(6) 2020 to exchange the inlay to crosslinked pe and plug-on head with metal sleeve / ceramic.A thorough debridement was also performed.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the ana.Nova ii ce insert 48 dia 36 delta is manufactured by a third party, this device is considered as a concomitant and no investigation will be performed by s&n, therefore, it was determined that this case does not meet the threshold for reporting and complaint criteria, this is a non-reportable event.If further details are provided confirming the opposite, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: ANA.NOVA II CE INSERT 48 DIA 36 DELTA
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10722092
• MDR Text Key: 212596512
• Report Number: 9613369-2020-00215
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75008438
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 01/12/2021; 01/13/2021
• Supplement Dates FDA Received: 12/18/2020; 01/13/2021; 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NANOS FEMORAL NECK PROSTHESIS NONCEM 7 (75008161)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR