MAUDE Adverse Event Report: AESCULAP AG COLUMBUS CR FEMORAL COMP.CEMENTED F5R; KNEE ENDOPROSTHETICS

Model Number NN015K

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with product columbus cr femoral.In (b)(6) 2020, the patient reacted to the material and was even removed to place a cement spacer.A revision surgery was necessary.Additional information was not provided nor available / was not available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).According to the customer complaint the first surgery was performed on (b)(6) 2019 with the following materials: involved components: nn434 (52363801), nr075k (52451742), nr192k (52411805), nx041 (52416529) ge241su (52408661).

Manufacturer Narrative

Investigation results: the devices were not received for investigation.The device history records have been checked for the available lot numbers and found to be according to the specifications, valid at the time of production.No further complaints registered against the same lot numbers.A clear conclusion can not be drawn.Based on the device history records, there is no indication for a material or manufacturing error.Therefore we assume that the failure is most probably not product related.It can´t be determined why an allergic reaction occured.A capa is not necessary.

• Brand Name: COLUMBUS CR FEMORAL COMP.CEMENTED F5R
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10284727
• MDR Text Key: 199268685
• Report Number: 9610612-2020-00308
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K022672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

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
• Device Operator: Health Professional
• Device Model Number: NN015K
• Device Catalogue Number: NN015K
• Device Lot Number: 52435449
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GE241SU-52408661; NN434-52363801; NR075K-52451742; NR192K-52411805
• Patient Outcome(s): Required Intervention