MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F2 LM; KNEE ENDOPROSTHESES

Model Number NO186Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Investigation results: visual investigation: the tibial component show bone cement residues on the whole intended area/ coated surface.This indicates that a loosening between the bone and bone cement has taken place.A partial overhang of bone cement is visible.The bone cement residues from the tibial component shows only a partly good bone anchorage (cement interlock into the bone trabeculae) has taken place.No drilling was performed on the bone as retention for the bone cement.The femur component shows no bone cement residues.The visible discoloration at the femoral component is a result of oxidation and does not affect the material properties in any way.The meniscal components show little imprints and scratches, which probably resulting from third body wear (bone chips and/or bone cement residues).Two of the provided x-ray figures show a bony loosening of the tibial component.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

It was reported that there was an issue with no186z - as univation xf femur cemented f2 lm.According to the complaint description, there was a revision due to loosening.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00127 ((b)(4) + no163z).Involved components nl471 - univation f meniscal comp.T2 rm/lm 7mm - (b)(4).

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F2 LM
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11745900
• MDR Text Key: 264294113
• Report Number: 9610612-2021-00315
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO186Z
• Device Catalogue Number: NO186Z
• Device Lot Number: 52410384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention