MAUDE Adverse Event Report: AESCULAP AG AS TIBIAL OBTURATOR D12MM; KNEE ENDOPROSTHETICS

Model Number	NN261Z
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
Event or Problem Description
It was reported to aesculap inc.That a vega knee system (part # unknown) was implanted during a procedure on (b)(6) 2016.According to the complaint there was a postoperative loosening of the implant.X rays show that the cement did not adhere to the implants or the bone.Reportedly the patient complained of right knee pain after the initial procedure.The patient underwent a revision surgery on (b)(6) 2022.The adverse event is filed under aic reference (b)(4).Reference associated medwatch reports: (b)(4) (2916714-2023-00093) ae-qas-k521-56, (b)(4) (2916714-2023-00094) ae-qas-k521-56.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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 not able to be reviewed as no lot number was made available.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.
Additional Manufacturer Narrative
Additional information received february 07 2024: d1 brand name, d4 additional device information, f9 approximate age of the device.

• Brand Name: AS TIBIAL OBTURATOR D12MM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17884975
• Report Number: 2916714-2023-00092
• Device Sequence Number: 7429624
• Product Code: OOG
• UDI-Device Identifier: 04046963124502
• UDI-Public: 4046963124502
• 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,Followup
• Report Date (Section B): 02/16/2024
• Report Date (Section F): 10/06/2023

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: 04/30/2026
• Device Model Number: NN261Z
• Device Catalogue Number: NN261Z
• Device Lot Number: 52239592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2023
• Device Age: 93 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/29/2023; 02/16/2024
• 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: 10/06/2023