MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV FEM.SPACER DIST.F5 10MM; KNEE ENDOPROSTHESES

Model Number	NR475Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, they will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with columbus knee implants via information received from mw5099720.According to the complaint description, an adverse event occurred involving her aesculap left knee implant.Patient stated that she had this knee implanted in 2018 and noticed in 2019 that she began having severe pain.Patient stated that her doctor did a bone scan which showed the implant has lifted and become loose.Patient stated her doctor told her the implant will need to come out.There was a permanent impairment.Additional information was not provided nor available / was not available.The adverse event is filed under xc reference (b)(4).Associated components: nr049z - lot 52345948.
Additional Manufacturer Narrative
D1 - clarified brand name.F9 - age of device.Reference code nr475z, device name as columbus rev fem.Spacer dist.F5 10mm, serial number n/a, batch number 52360025, manufacturing date 25.08.2017.Reference code nr049z, device name as columbus tib.Hemi-sp.T2/2+ 10mm rm/ll, serial number n/a, batch number 52345948, manufacturing date 14.06.2017.Investigation: no product at hand, therefore an investigation is not possible.Pictorial documentation: there are no pictures available.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: there are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.In the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a definitive root cause for the mentioned failure.The devices listed (nr475z and nr049z) are only additional components for the tibial-and femoral component.No clear failure can be assigned to these articles.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa request necessary.
Event or Problem Description
No updates.

• Brand Name: AS COLUMBUS REV FEM.SPACER DIST.F5 10MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11756577
• Report Number: 2916714-2021-00061
• Device Sequence Number: 17025997
• Product Code: JWH
• UDI-Device Identifier: 04046963175900
• UDI-Public: 4046963175900
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021
• Report Date (Section F): 04/23/2021

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: NR475Z
• Device Catalogue Number: NR475Z
• Device Lot Number: 52360025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NR049Z-52345948
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 04/23/2021