MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1R; KNEE ENDOPROSTHETICS

Model Number NB017Z

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

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 ae-qas-k521-55 - collect.No.Qas knee implants rotat.Hinge.According to the complaint description, the patient needs their current aesculap enduro as knee revision femoral component converted to a customized femoral component that can fix into the remaining healthy bone.A revision surgery was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under (b)(4).

Event Description

Additional information received on 03.Sep.2021 multiple unspecified knee surgeries were performed prior to this.Initial surgery date: (b)(6) 2020.Involved components: nr400z - as nut f/femur extens.Stem all sz.Neutr.- lot 52553246; nr440z - as femur extens.Stem 5° d20x177 cem.Less - lot 52350154; nr873z - as enduro meniscal component f1 16mm - lot unknown.

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.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F1R
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12407850
• MDR Text Key: 280948520
• Report Number: 9610612-2021-00529
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• 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: 09/30/2021

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: NB017Z
• Device Catalogue Number: NB017Z
• Device Lot Number: 52537585
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NR400Z - LOT 52553246; NR440Z - LOT 52350154; NR873Z - LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR