MAUDE Adverse Event Report: AESCULAP AG BIOLOX DELTA PROSTH.HEAD 12/14 32MM M; PROSTHETICS

Model Number	NK561D
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with nk561d-biolox delta prosth.Head 12/14 32mm m.According to the complaint description, the delta head does not fit.Delta ceramic head could not be placed on a metha nc293t.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: nc293t-metha cap 12/14 120°/0° size 3 - 52634100.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information/investigation results will be provided in a supplemental report.
Additional Manufacturer Narrative
Investigation results: visual investigation: there are stains and scratches on the surface.The component was examined visually and microscopically.The component is in a clean decontaminated condition.The underside, there are scratches/scuff marks on the bottom edge of the sphere.There are marks/abrasions on the surface of the sphere.There are stains/abrasions on the surface of the other side of the sphere.You can see scratches/metal transfer on the surface of the cone.These all scratches/abrasions/metal transfer probably occurred when trying to insert the ball.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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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
Involved components: nc293t - metha cap 12/14 120°/0° size 3 - lot 52634100.

• Brand Name: BIOLOX DELTA PROSTH.HEAD 12/14 32MM M
• Common Device Name: PROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12900953
• Report Number: 9610612-2021-00754
• Device Sequence Number: 4802485
• Product Code: LZO
• UDI-Device Identifier: 04046963190460
• UDI-Public: 4046963190460
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: NK561D
• Device Catalogue Number: NK561D
• Device Lot Number: 52685509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NC293T - 52634100; NC293T - LOT 52634100
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown