MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F FEMUR CEMENTED F5R; KNEE ENDOPROSTHESES

Model Number	NR015K
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561)
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.No product is available and therefore it is hardly possible to determine an exact conclusion and root cause.The exact cause cannot be determined.For the topic (implant loosening) a product safety case was initiated.
Event or Problem Description
It was reported that there was an issue with nr015k - columbus rev f femur cemented f5r it was reported on (b)(6) 2018, that as a result of having the product implanted, the patient has experienced looseness in the implant, pain and difficulty walking, which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2015, and the revision surgery occurred on (b)(6) 2016.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event is filed under aag reference (b)(4).Components: nr134m (columbus rev f mc glid surf t3/3+ 18mm).The cement used is unidentified.

• Brand Name: COLUMBUS REV F FEMUR CEMENTED F5R
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11679908
• Report Number: 2916714-2020-00377
• Device Sequence Number: 3052268
• Product Code: JWH
• UDI-Device Identifier: 04046963337643
• UDI-Public: 4046963337643
• 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: 2015
• Device Explanted Year: 2016
• 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): 04/16/2021
• Report Date (Section F): 04/16/2021

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: NR015K
• Device Catalogue Number: NR015K
• 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: 04/16/2021
• 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: 04/16/2021