MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEM.SPACER POST/DIST F2 12X4MM; KNEE ENDOPROSTHESES

Model Number	NR592Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2023
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 as enduro fem.Spacer post/dist f2 12x4mm (part # nr592z) was implanted (b)(6) 2020.According to the complainant the implant had become loose and the patient underwent a revision surgery on (b)(6) 2023.No patient complications were reported as a result of the revision procedure.The adverse event is filed under aic reference (b)(4).Reference associated medwatch reports: 2916714-2023-00064, 2916714-2023-00069, 2916714-2023-00071, 2916714-2023-00072 and 2916714-2023-00073.
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: AS ENDURO FEM.SPACER POST/DIST F2 12X4MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17074621
• Report Number: 2916714-2023-00070
• Device Sequence Number: 6738881
• Product Code: KRO
• UDI-Device Identifier: 04046963937485
• UDI-Public: 4046963937485
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2023
• Report Date (Section F): 06/06/2023

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 Model Number: NR592Z
• Device Catalogue Number: NR592Z
• Device Lot Number: 52325498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/17/2023
• Device Age: 74 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 10/14/2023
• 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: 54 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/06/2023