MAUDE Adverse Event Report: AESCULAP AG BIOLOX DELTA PROSTH.HEAD 12/14 36MM M; HIP ENDOPROSTHETICS

Model Number NK651D

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with biolox delta prosth.Head.It was reported that the label does not correspond with the product to which is attached.There was no patient harm.There was no surgery delay.Additional 'informtaion' has been requested but not yet received as of this report.The malfunction is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about a nk651d - biolox delta prosth.Head 12/14 36mm m.We did not receive the product nor the label for investigation.Investigation: no investigation possible, due to the lack of components.Batch history review: the device history records have been checked for the available lot number (52533512) and found to be according to the specification, valid at the time of production.There is no indication for a labelling/manufacturing failure.The retention sample is correct and shows no deviation.No further complaints registered against the same lot number.Conclusion and root cause: the failure is most probably not product related.There is no indication for a product related failure.Rationale: on the basis of the provided information and without the product/label, a clear conclusion can not be drawn.After a review of the device history records, there is no indication for a labelling/manufacturing failure.Corrective action: a capa is not necessary according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action).

• Brand Name: BIOLOX DELTA PROSTH.HEAD 12/14 36MM M
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9476071
• MDR Text Key: 179419589
• Report Number: 9610612-2019-00878
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K082991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK651D
• Device Catalogue Number: NK651D
• Device Lot Number: 52533512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1