MAUDE Adverse Event Report: AESCULAP AG VEGA PS GLIDING SURFACE T4/4+ 10MM; KNEE ENDOPROSTHESES,

Model Number	NX140
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a vega knee implant was implanted on an unspecified date.According to the complainant the implant had fractured.Reportedly the patient underwent a revision on an unspecified date.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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
Update: the complained product was nx140 - vega ps gliding surface t4/4+ 10mm.There was a polyethylene fracture postoperatively on the left total knee; positive "posterior drawer".Associated user medwatch report: mw5153839.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 T4/4+ 10MM
• Common Device Name: KNEE ENDOPROSTHESES,
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19228522
• Report Number: 2916714-2024-00082
• Device Sequence Number: 12507517
• Product Code: JWH
• UDI-Device Identifier: 04046963810948
• UDI-Public: 04046963810948
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024
• Report Date (Section F): 05/02/2024

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: 03/01/2015
• Device Model Number: NX140
• Device Lot Number: 51655957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2024
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Date Report Sent to FDA: 05/02/2024