MAUDE Adverse Event Report: AESCULAP AG BIOLOX DELTA PROSTH.HEAD 12/14 36MM S; HIP ENDOPROSTHESES - STEMS

Model Number NK650D

Device Problem Component Incompatible (1108)

Patient Problem Failure of Implant (1924)

Event Date 04/09/2021

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 nk650d - biolox delta prosth.Head 12/14 36mm s.According to the complaint description, the surgeon complains about the too tight head / conus connection in the exciat: intraoperatively, he had to change a used s head to an l head after reduction.Despite all his efforts, the stem came along with it when it was cut off.He then implanted a new 13 mm shaft and an l head.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00372, (b)(4) + nu213t).

Manufacturer Narrative

Updated h6: codes.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.  investigation results: visual investigation: the provided hip implant components show no deviation or abnormalities.The provided components were examined visually and microscopically.Furthermore this case was discussed with a specialist from the product management.In the delivered condition the nk650d -> biolox delta prosth.Head 12/14 36mm s is still fixed on the nu213t -> excia t plasmapore 12/14 size 13mm.The cone connection of both components shows no abnormalities.  batch history review:  the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.  review of the complaint history revealed that no similar complaints have been filed against products from this batch number.  conclusion and measures / preventive measures:  based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Associated medwatch-reports: 9610612-2021-00372 ((b)(4)+ nu213t).

• Brand Name: BIOLOX DELTA PROSTH.HEAD 12/14 36MM S
• Type of Device: HIP ENDOPROSTHESES - STEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11806653
• MDR Text Key: 256455460
• Report Number: 9610612-2021-00373
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04046963190491
• UDI-Public: 4046963190491
• 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: 09/09/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NK650D
• Device Catalogue Number: NK650D
• Device Lot Number: 52637439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention