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: additional information / investigation results will be provided in a supplemental report, if available.

Event Description

It was reported that there was an issue with ae-qas-k521-55 - collect.No.Qas knee implants rotate 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 has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.

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: the components used were the following: 4x cement bone full dose radiopaque simplex (stryker).Nr400z1 as nut f/femur extens.Stem all sz.Neutr(aesculap inc.); implant site: right knee lot number: 52553246.Nr440z as femur extens.Stem 5° d20x177 cem.Less (aesculap inc.); implant site: right knee lot number: 52350154.Nr873z as enduro meniscal component f1 16mm (aesculap inc.); implant site: right knee.

Event Description

No updates.

Manufacturer Narrative

The components used were the following: 4x cement bone full dose radiopaque simplex (stryker) nr400z1 as nut f/femur extens.Stem all sz.Neutr(aesculap inc.); implant site: right knee lot number: 52553246.Nr440z as femur extens.Stem 5° d20x177 cem.Less (aesculap inc.); implant site: right knee lot number: 52350154.Nr873z as enduro meniscal component f1 16mm (aesculap inc.); implant site: right knee.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: 12396161
• MDR Text Key: 269725330
• Report Number: 2916714-2021-00174
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2021,10/08/2021

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Distributor Facility Aware Date: 08/12/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/27/2021; 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR