MAUDE Adverse Event Report: AESCULAP AG EXCIA L PLASMAPORE 12/14 SIZE 9MM; HIP ENDOPROSTHESES - STEMS

Model Number NK599T

Device Problem Break (1069)

Patient Problems Fall (1848); Joint Disorder (2373)

Event Date 06/22/2020

Event Type  Injury  

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 the product excia l plasmapore 12/14 size 9mm.Specifically, it was reported that x-rays revealed that it came to a neck fracture of the shaft following a fall on the left side of the body.A revision surgery was necessary.Additional information has been requested but not yet received as of the date of this report.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00266 (cc 400476998 + nk650d).Involved components: nk650d - biolox delta prosth.Head 12/14 36mm s - 52144181.

Manufacturer Narrative

Investigation results: the following articles were identified by the investigation as involved components: nv154t plasmafit plus cup size 54mm h 52132375 nv114d biolox delta insert h 36mm sym.52137267 nk650d biolox delta prosth.Head 12/14 36mm s 52144181 only the broken shaft (nk599t) is defined as a leading component.The complaint device was provided and investigated.Several x-rays and intraoperative pictures wer sent by customer as well.The fracture of the shaft occurred in the proximal area at the transition from shaft to neck just above the proximal plasmapore coating.The material composition has been checked by non-destructive x-ray fluorescence analysis and shows no signs of deviation.The material hardness was checked with a hardness test, no indications of a deviation could be found.The x-rays provided by the clinic and the operation reports do not give any concrete indication of the root cause of the fracture.The device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and find to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.The failure of the implant is due to a fatigue fracture.It is not possible to determine a clear root cause for the failure.Most probably the failure is not product related.Since we have no information on the patient such as activity level or weight, it is not possible to conclusively determine the cause of the fracture on the basis of the information and examinations available.There are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.On the lateral side at the origin of the breakage a small damage to the material can be determined: therfore it could be possible that this damage was caused during implantation and consequently contributed to the fracture of the implant.

Event Description

Associated medwatch-reports: 9610612-2020-00266 (cc 400476998 + nk650d), involved components: nv154t - plasmafit plus cup size 54mm h - lot 52132375, nv114d - biolox delta insert h 36mm sym.- lot 52137267, nk650d - biolox delta prosth.Head 12/14 36mm s - 52144181.

• Brand Name: EXCIA L PLASMAPORE 12/14 SIZE 9MM
• Type of Device: HIP ENDOPROSTHESES - STEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10295531
• MDR Text Key: 202762074
• Report Number: 9610612-2020-00264
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K061344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: NK599T
• Device Catalogue Number: NK599T
• Device Lot Number: 51407477
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: - BIOLOX DELTA PROSTH.HEAD; NK650D - 52144181; NV114D - 52137267; NV154T - 52132375
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR