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

Model Number NO157Z

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

Patient Problem Failure of Implant (1924)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with product as univation xf tibia.According to the complaint description, it was reported that the implant on the right side is loosening after 1 year and 27 days.A revision surgery was 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: 9610612-2020-00676 (b)(4).Involved components: univation f meniscal comp.T2 rm/lm 9mm - 52204900.

Manufacturer Narrative

Investigation results: visual investigation: to date there is no device available for investigation.Therefore, no investigation possible.Batch history review: 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.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Further investigation will be done under internal psc.

Event Description

The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00676 (400487340 no181z); 9610612-2020-00677 (400487341 no157z).Involved components: univation f meniscal comp.T2 rm/lm 9mm: 52204900.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T2 RM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10844544
• MDR Text Key: 216397554
• Report Number: 9610612-2020-00677
• 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
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO157Z
• Device Catalogue Number: NO157Z
• Device Lot Number: 52381566
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL483-52204900; NL483-52204900
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR