MAUDE Adverse Event Report: AESCULAP AG AS FEMUR EXTENS.STEM 5° D12X117 CEM.LESS; KNEE ENDOPROSTHETICS

Model Number	NR402Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That an as femur extens.Stem 5° d12x117 cem.Less.(part # nr402z) was implanted in a patient on (b)(6) 2021.According to the complainant the patient currently presents with tibial base plate loosening and continued left painful knee arthroplasty.Reportedly a revision procedure was scheduled for (b)(6) 2024.The adverse event is filed under aic reference (b)(4).Associated medwatch reports: 2916714-2024-00186 (aic reference no.(b)(4), 2916714-2024-00187 (aic reference no.(b)(4), 2916714-2024-00188 (aic reference no.(b)(4), 2916714-2024-00189 (aic reference no.(b)(4), 2916714-2024-00190 (aic reference no.(b)(4), 2916714-2024-00191 (aic reference no.(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
Additional information: a2 patient age.A4 patient weight.B7 relevant history.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 FEMUR EXTENS.STEM 5° D12X117 CEM.LESS
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20722510
• Report Number: 2916714-2024-00189
• Device Sequence Number: 6639560
• Product Code: KRO
• UDI-Device Identifier: 04046963176525
• UDI-Public: (01)04046963176525(11)180614(17)280531(10)52431742
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024
• Report Date (Section F): 11/19/2024

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 Model Number: NR402Z
• Device Catalogue Number: NR402Z
• Device Lot Number: 52431742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/01/2024
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/19/2024
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Date Report Sent to FDA: 11/19/2024