MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS TIBIAL PLATEAU CEMENTED T3; KNEE ENDOPROSTHETICS

Model Number	NX055Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That an ps tibial plateau cemented t3 (item nx055z) was implanted on (b)(6) 2013.According to the complainant, there was a gross loosening of the femoral and tibial components of the right knee.The patient underwent revision surgery on july 20 2021.The adverse event/malfunction is filed under aic reference xc 100032169 cc 400582818 associate medwatch reports 400582819_ 2916714-2023-00002_mdr, 400582820_ 2916714-2023-00003_mdr, 400582821_ 2916714-2023-00004_mdr, 400582822_ 2916714-2023-00005_mdr.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Additional information - f9 (approximate age of device).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.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.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.

• Brand Name: AS VEGA PS TIBIAL PLATEAU CEMENTED T3
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16207520
• Report Number: 2916714-2023-00001
• Device Sequence Number: 5454245
• Product Code: JWH
• UDI-Device Identifier: 04046963810450
• UDI-Public: 4046963810450
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023
• Report Date (Section F): 01/19/2023

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 Expiration Date: 08/31/2017
• Device Model Number: NX055Z
• Device Catalogue Number: NX055Z
• Device Lot Number: 51873261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/22/2022
• Device Age: 132 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 09/18/2023
• 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: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/19/2023