MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F2 RM; FEMUR IMPLANTS UNIVATION

Model Number NO181Z

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 femoral-as well as the tibial component show no device failure or serious damage.The components were examined visually and microscopically.The provided femoral component show bone cement residues on almost the whole intended area/ coated surface.This indicates that a loosening between the bone and bone cement has taken place.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 2 similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x prbability 2(5) of occurrence) according to din en iso 14971 is still acceptable.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 no181z - as univation xf femur cemented f2 rm.According to the complaint description, a revision surgery was necessary due to loosening of implants.Loosened and virtually no cement integration at all.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00413 ((b)(4)).9610612-2021-00288 ((b)(4)).Involved components (aufführen in d11 + c2) nl471 - univation f meniscal comp.T2 rm/lm 7mm - lot 52502902.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F2 RM
• Type of Device: FEMUR IMPLANTS UNIVATION
• 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: 11856129
• MDR Text Key: 251740340
• Report Number: 9610612-2021-00413
• 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: 05/20/2021

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
• Device Operator: Health Professional
• Device Model Number: NO181Z
• Device Catalogue Number: NO181Z
• Device Lot Number: 52518557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NL471
• Patient Outcome(s): Required Intervention