MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1R; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number NB017Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ambulation Difficulties (2544); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as lot # of the device in question was not known.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

It was reported to aesculap inc.That a vega knee implant system was implanted during a primary surgery of the left knee performed on (b)(6) 2014.According to the complainant, following the primary surgery, the patient experienced knee pain, difficulty walking, as well as loosening and instability of the implant.There was no reported revision surgery.The complaint device was not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F1R
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11739618
• MDR Text Key: 247786652
• Report Number: 2916714-2020-00636
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04046963177539
• UDI-Public: 4046963177539
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2021
• Distributor Facility Aware Date: 04/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other