MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F5R; KNEE ENDOPROSTHETICS

Model Number	NX032Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That an as vega ps femoral comp.Cemented f5r (part # nx032z) was implanted during a primary procedure performed approximately five (5) years ago by another surgeon.According to the complainant, postoperative loosening of the implant occurred.Reportedly, the cement did not adhere to the implants or the bone.The patient underwent a revision surgery on (b)(6) 2022.The complaint device was not returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision surgery.The adverse event / malfunction is filed under aic reference (b)(4).Associated medwatch report: (b)(4) (2916714-2022-00103) ae-qas-k521-56.(b)(4) (2916714-2022-00104 ) ae-qas-k521-56.
Additional Manufacturer Narrative
Manufacturing site evaluation: 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
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.However, a picture of the implant was provided for analysis; an examination of the image revealed no connection/adhesive between cement and implant, and no cement connection/adhesive to the bone.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 FEMORAL COMP.CEMENTED F5R
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15605328
• Report Number: 2916714-2022-00102
• Device Sequence Number: 11296789
• Product Code: JWH
• UDI-Device Identifier: 04046963810184
• UDI-Public: 4046963810184
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023
• Report Date (Section F): 10/14/2022

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: 09/30/2025
• Device Model Number: NX032Z
• Device Catalogue Number: NX032Z
• Device Lot Number: 52185341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2022
• Device Age: 83 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 01/19/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/14/2022