MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T4; PROSTHESIS, KNEE

Model Number	NN077Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an as columbus cr/ps tib.Plat.Cemented t4 (part# nn077z) was implanted in a patient's right knee sometime in 2022.According to the complaint description, the revision surgery was planned for (b)(6) 2024.Reportedly the reason for the surgery was due to a screw coming lose in the construct, as such, the implant was floating around in the joint.The polyethylene components would be removed and replaced.The adverse event is filed under aesculap reference number (b)(4): 2916714-2024-00130 (aic reference no.(b)(4)), 2916714-2024-00148 (aic reference no.(b)(4)), 2916714-2024-00150 (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
Investigation results: 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.Batch history review: 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.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 20494863
• Report Number: 2916714-2024-00149
• Device Sequence Number: 19709719
• Product Code: JWH
• UDI-Device Identifier: 04046963119072
• UDI-Public: (01)04046963119072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/18/2024
• Report Date (Section F): 10/21/2024

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: NN077Z
• Device Catalogue Number: NN077Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/18/2024
• 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: Male
• Date Report Sent to FDA: 10/21/2024