MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F HC GLID.SURF.T3/3+ 16MM; KNEE ENDOPROSTHESES

Model Number	NR633M
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with the product columbus rev glid.Surf.Specifically, it was reported that an aesculap columbus revision knee was revised due to instability 1 year and 4 months postoperatively.The original surgery date was (b)(6)2019.The surgeon removed the old insert and implanted a new insert of a larger thickness; the replacement was also a columbus component.No components were noted as loose.A revision surgery was necessary.Additional information is not available.The adverse event is filed under reference (b)(4).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Device reference code: (b)(4).Device name columbus rev f hc glid.Surf.T3/3+ 16mm.Serial number: n/a.Batch number: 52150736.Udi device identifier: (b)(4).Udi production identifier: (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 2015-07-03.There are no explants available for investigation.Investigation: failure description; no product at hand - therefore a failure description is not possible.Investigation: no product at hand - therefore a failure 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 available 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 root cause for the mentioned failure.Conclusion and root cause: due to the current deviation and according to the rationale, it is not possible to determine a root cause for the mentioned failure.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

• Brand Name: COLUMBUS REV F HC GLID.SURF.T3/3+ 16MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10233618
• Report Number: 2916714-2020-00202
• Device Sequence Number: 18981222
• Product Code: JWH
• UDI-Device Identifier: 04046964010002
• UDI-Public: 4046964010002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: 05/31/2020
• Device Model Number: NR633M
• Device Catalogue Number: NR633M
• Device Lot Number: 52150736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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: 64 YR