MAUDE Adverse Event Report: AESCULAP AG PLUG F/TIBIAL PLATEAU; KNEE ENDOPROSTHETICS

Model Number	NN260P
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
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
It was reported to aesculap inc.That a plug f/tibial plateau (item nn260p) 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 (b)(6) 2021.The adverse event/malfunction is filed under aic reference (b)(4).Associate medwatch reports: 400582818_ 2916714-2023-00001_mdr, 400582819_ 2916714-2023-00002_mdr, 400582820_ 2916714-2023-00003_mdr, 400582821_ 2916714-2023-00004_mdr.
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.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: PLUG F/TIBIAL PLATEAU
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16207523
• Report Number: 2916714-2023-00005
• Device Sequence Number: 14816380
• Product Code: JWH
• UDI-Device Identifier: 04046963711320
• UDI-Public: 4046963711320
• 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: 12/31/2017
• Device Model Number: NN260P
• Device Catalogue Number: NN260P
• Device Lot Number: 51910799
• 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: 128 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