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

Model Number	NB017Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11739618
• Report Number: 2916714-2020-00636
• Device Sequence Number: 3029322
• Product Code: KRO
• UDI-Device Identifier: 04046963177539
• UDI-Public: 4046963177539
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021
• Report Date (Section F): 04/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: NB017Z
• Device Catalogue Number: NB017Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 04/28/2021