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

Model Number NO186Z

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: pending further information.

Event Description

Patient revised on (b)(6) 2018.Additional information has been requested, but not yet received.No patient injury was reported.No delay in surgery was reported.Components in use listed as concomitant devices are: no166z, as univation xf tibia cemented t5 lm, batch # 52080219.Nl478, univation f meniscal comp.T3 rm/lm 8mm, batch # 51974137.

Manufacturer Narrative

The components have been examined visually and microscopically with the digital microscope.A visual inspection took place of the femoral component and the tibial plateau.At the femoral component, bone cement can be found at the area of the condyle.At the tibial plateau, only little residues of the bone cement can be found.The device quality and manufacturing history records have been checked to all the available lot numbers.The device history file has been checked and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from these batches.Based on the information available it is hardly possible to determine a conclusion and the root cause for the mentioned failure.We assume that the failure is not product related.It could be possible that the failure is usage related.Due to lack of information it is hardly possible to determine a conclusion and root cause.There are no hints for a material problem.According to the quality standard and dhr files a material defect and production error can be excluded.It could be possible that there were problems with the cement technique.Some time ago an internal extensive bone cement test with another two complained devices was carried out in the laboratory of biomechanics with a specialist from the product management research.Due to the fact that the mentioned cement test achieved a positive result, we excluded a product or design related error.A capa was created.The current failure rate is outside the risk analysis, risk analysis has to be adjusted by r&d.

Manufacturer Narrative

We received a complaint about one no186z (as univation xf femur cemented f2 lm) from the memorial hospital in baltimore.There is no device available for investigation.Loosening of the implant 3 years postoperatively.The implantation date is 13 sept 2015 and the revision date is unknown.The consequences for the patient is post-operative medical intervention was neccessary for a revision surgery.In the batch review, the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Based on the information, it is hardly possible to determine a conclusion and the root cause for the mentioned failure.We assume that the failure is not product related.It could be possible that the figure is usage related.Due to lack of information and the circumstance that we did not receive the devices for the investigationit is hardly possible to determine a conclusion and root cause.There are no hints for a materials problem.According to the quality standard and dhr files a materials defect and production error can be excluded.It could be possible that there were problems with the cement techniques.Potential sources of fault relating to the cement: the process time of the used cements was excedded, wrong temperature, unfavourable storage, the age of the cement and wrong handling with the cement.Some time ago an internal extensive bone cements test (adhesive tensile testing) with another two complained devices were carried out in the laboratory of biomechanic with a specialist from the product management and biomechanical research.Due to the fact that the mentioned cement test achieved a positive result, we exclude a product or design related error.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F2 LM
• Type of Device: FEMUR IMPLANTS UNIVATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7915181
• MDR Text Key: 121912752
• Report Number: 9610612-2018-00428
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: NO186Z
• Device Catalogue Number: NO186Z
• Device Lot Number: 51986203
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/19/2018
• Device Age: 51 MO
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL478; NO166Z; NL478; NO166Z
• Patient Outcome(s): Required Intervention