MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T2 LM; KNEE ENDOPROSTHETICS

Model Number NO163Z

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

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

General information we received a complaint about one no163z as univation xf tibia cemented t2 lm from (b)(6).The provided components were decontaminated internally according to internal standards.Some x-ray figures were provided to us.The following information was provided: 8m po loosening of tibia component.Loosening of the tibial component t2 lm, suspected loosening of the femoral component.Actually, however, during explantation femoral component firmly anchored and connected with cement, tibial component loose but with intact cement mantle, loosening in the interface cement/bone.Consequences for the patient: post-operative medical intervention was necessary: revision surgery.Failure description: the femoral-as well as the tibial component show no serious damage.Investigation: the components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".The tibial component show bone cement residues on the whole intended area/ coated surface.The bone cement residues from the tibial component shows that a good bone anchorage.(cement interlock into the bone trabeculae) has taken place.The femur component show only little/partially bone cement residues.The meniscal component show no abnormal damage or other abnormalities.The cut on the backside of the implant most probably stem from the explantation procedure.This case was discussed with a specialist from the product management.Furthermore, regarding this case, the product management is in contact with the treating doctor.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers 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.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably patient related.Rationale: there are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.According to the product management and the available x-ray figures the univation prosthesis was well implanted.The tibial explant shows a bony loosening.There are several root causes for an implant loosening out of the bone bed: low grade infect (is examined by the doctor at that time).A bone cement allergy could also be a root cause for bony loosening of the cement.Corrective action: capa was created.

Event Description

It was reported that there was an issue with as univation xf tibia.According to the customer report: "loosening of the tibial component t2 lm, suspected loosening of the femoral component.Actually, however, during explantation femoral component firmly anchored and connected with cement, tibial component loose but with intact cement mantle, loosening in the interface cement/bone." a revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under (b)(4).Involved components: nl471 - univation f meniscal comp.T2 rm/lm 7mm - 52476195.No163z - as univation xf tibia cemented t2 lm - 52491331.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T2 LM
• Type of Device: KNEE ENDOPROSTHETICS
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9729113
• MDR Text Key: 180161566
• Report Number: 9610612-2019-01003
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO163Z
• Device Catalogue Number: NO163Z
• Device Lot Number: 52491331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2019
• 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
• Patient Outcome(s): Required Intervention