MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T6 RM; KNEE ENDOPROSTHETICS

Model Number NO161Z

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

Patient Problem Failure of Implant (1924)

Event Date 03/09/2019

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with product as univation tibia xf, left side.According to the complaint description it was reported that the implant loosening after 2 years and 1 month.A revision surgery was on (b)(6) 2019 necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2020-00667 ((b)(4) no183z).Involved components: collect.No.Qas knee implants univation -unknown (no information on the inlay).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00666 (400487356 no161z), 9610612-2020-00667 (400487357 no183z).Involved components: collect.No.Qas knee implants univation -unknown.No product at hand, therefore an investigation at the product is not possible.The provided x-ray figures give no hints regarding the root cause of the implant loosening.On the basis of the current information and without the complained devices, a clear conclusion cannot be drawn.A product safety case was initiated.Based on 8 d report no capa is necessary.

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00666 (400487356 no161z), 9610612-2020-00667 (400487357 no183z).The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.On the basis of the current information, a clear conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.There are no hints for a device problem.There are many factors which can lead to an implant loosening situation.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T6 RM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10844662
• MDR Text Key: 216399760
• Report Number: 9610612-2020-00666
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

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: NO161Z
• Device Catalogue Number: NO161Z
• Device Lot Number: 52194935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 12/03/2020
• Supplement Dates FDA Received: 11/23/2020; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COLLECT.NO-UNKNOWN; COLLECT.NO-UNKNOWN; COLLECT.NO-UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR