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

Model Number	NK650D
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem 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).
Additional 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 or Problem Description
Associated medwatch-reports: 9610612-2021-00372 ((b)(4)+ nu213t).

• Brand Name: BIOLOX DELTA PROSTH.HEAD 12/14 36MM S
• Common Device Name: HIP ENDOPROSTHESES - STEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11806653
• Report Number: 9610612-2021-00373
• Device Sequence Number: 19716553
• Product Code: LZO
• UDI-Device Identifier: 04046963190491
• UDI-Public: 4046963190491
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention