MAUDE Adverse Event Report: AESCULAP AG COREHIP STD CEMENTLESS 12/14 SIZE 3; HIP ENDOPROSTHESES - STEMS

Model Number	NK1003T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
Event or Problem Description
It was reported to aesculap ag that a corehip std cementless 12/14 size 3 (part # nk1003t) was implanted during a total hip arthroplasty (tha) procedure performed on (b)(6) 2021.According to the complainant, two (2) weeks after the tha surgery, a subduction of about 2 millimeters (mm) occurred.After approximately 21 days, a spiral fracture occurred from the lateral part of the stem to the distal part.The patient was scheduled for a revision surgery for (b)(6) 2022.The plan is to replace the stem with another manufacturer's device.The complaint device has not been returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

• Brand Name: COREHIP STD CEMENTLESS 12/14 SIZE 3
• Common Device Name: HIP ENDOPROSTHESES - STEMS
• 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: 13446711
• Report Number: 9610612-2022-00006
• Device Sequence Number: 19913872
• Product Code: LZO
• UDI-Device Identifier: 04046964680250
• UDI-Public: 4046964680250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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: NK1003T
• Device Catalogue Number: NK1003T
• Device Lot Number: 52666148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female