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

Model Number NO163Z

Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

General information: we received a complaint regarding univation implants from the (b)(4).In the meantime several explants are available for investigation in a decontaminated condition this is the second report.The first report can be found within cc 400473156.Consequences for the patient.Post-operative medical intervention was necessary: revision surgery.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".In the delivered condition there are no bone cement residues on the tibial component.The plasma pore coating shows no abnormalities or damages.The femoral component shows bone cement residues nearly on the whole intended area.The gliding surface of the meniscal component shows little scratches and imprints probably resulting from third body wear (bone chips and/or bone cement residues.The provided picture/x-ray figures give no hints regarding the root cause of the implant loosening.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 it is not possible to determine a definitive root cause for the failure.It could be possible that the failure is usage related.Rationale: on the basis of the current information, a clear conclusion can not be drawn.The device history records have been checked and no abnormalities could be observed.There are no hints for a material/device problem.Based on the information provided and the conclusion from our investigation we assume that only the tibial component has been loosened.It could be possible that there were problems with the cement technique.If cement was not on the implant, the failure was between implant and cement interface.Possible reason for loosening could be: a wrong handling with the cement.The plasmapore coated surface has been contaminated with fat or blood before the cement was applied.The gloves of the nurse were not changed/ were decontaminated when touching the cement.So fat and/ or blood was on the cement.Corrective action: product safety case was created.

Event Description

It was reported that there was an issue with tibia cemented.It was reported that no cement adhered to the prosthesis.The cement surface was completely smooth.The tibial component was as if unused.Primary surgery was on (b)(6) 2019.Revision surgery was on (b)(6) 2020.Additional cc´s created.Awareness date: (b)(6) 2020.9610612-2020-00283 (400476804 no163z) as a leading material and due do the facts reportable.Upon review of the 8 d report, the leading material is 400476804 with the article number no163z.The case 400473156 with the article number no187z is a involved component.Therefore it is not being reported accordingly.All available information has been included.Involved components: nl483-52369046.

• 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: nadine schweikart ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10245625
• MDR Text Key: 199838231
• Report Number: 9610612-2020-00283
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 52410669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2018
• 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
• Patient Age: 63 YR