MAUDE Adverse Event Report: AESCULAP AG VEGA PS GLIDING SURFACE T2/2+ 12MM; KNEE ENDOPROSTHESES

Model Number	NX121
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a vega ps gliding surface t2/2+ 12mm (part # nx121) was implanted during a procedure on (b)(6) 2016.According to the complaint there was a postoperative loosening of the implant at the femoral componant.X rays show that the cement did not adhere to the implants or the bone.Reportedly the paitent complained of right knee pain after the initial procedure.The patient underwent a revision surgery on (b)(6) 2022.Additional information was received on february 7 2024 with the item an lot information.The adverse event is filed under aic reference (b)(4) (b)(4) (2916714-2023-00092) nn261z.(b)(4) (2916714-2023-00093) nx029z.(b)(4) (2916714-2023-00094) nx042.(b)(4) (2916714-2024-00006) nx053z.
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.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: VEGA PS GLIDING SURFACE T2/2+ 12MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18735607
• Report Number: 2916714-2024-00008
• Device Sequence Number: 6292053
• Product Code: OOG
• UDI-Device Identifier: 04046963810832
• UDI-Public: 4046963810832
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024
• Report Date (Section F): 02/19/2024

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: 04/14/2026
• Device Model Number: NX121
• Device Catalogue Number: NX121
• Device Lot Number: 52233111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2023
• Device Age: 94 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/26/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 02/19/2024