MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS REV FEM.SPACER DIST.F5 5MM; KNEE ENDOPROSTHESES

Model Number	NR465Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.A clear root cause conclusion cannot be drawn due to the non-availability of important information and the device itself.The conclusion from the root cause analysis is that a systematic device deviation is unlikely, since the received complaints are limited to certain health care institutions and their applicants.The participation of the applicants in this deviation scenario cannot be excluded by today.Based on the root cause analysis result no corrective actions have been carried out.As a preventive action we were in contact with the affected health care institutions and applicants in order to reduce the probability of recurrence.The complaints were submitted to aesculap ag as a summary report.In order to examine further actions, all cases from the summary report are processed as vigilance suspicion cases and are continuously monitored.
Event or Problem Description
It was reported that there was an issue with columbus rev fem.Spacer.According to the complaint description that as a result of having the product implanted, the patient has experienced pain, difficulty walking, and loosening of the implant.Primary surgery: (b)(6) 2014 (non-aesculap implant).Revision surgery: (b)(6) 2017.Cement used was unidentified.A revision surgery was necessary.All available information has been provided at this time, if additional information becomes available the report will be updated accordingly.The adverse event is filed under xc reference (b)(4).

• Brand Name: AS COLUMBUS REV FEM.SPACER DIST.F5 5MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11436440
• Report Number: 2916714-2020-00298
• Device Sequence Number: 17162934
• Product Code: JWH
• UDI-Device Identifier: 04046963177171
• UDI-Public: 4046963177171
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2021
• Report Date (Section F): 03/08/2021

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: NR465Z
• Device Catalogue Number: NR465Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2021
• 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
• Date Report Sent to FDA: 03/08/2021