MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T4 LM; KNEE ENDOPROSTHESES

Model Number NO165Z

Device Problem Biocompatibility (2886)

Patient Problem Failure of Implant (1924)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

Event Description

It was reported that there was an issue with no165z - as univation xf tibia cemented t4 lm.According to the complaint description, there was a postoperative knee infection.The patient required a poly swap.During the replacement procedure, it was noted that the "femur fell off".A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under (b)(4).Associated medwatch reports: 9610612-2021-00332 ((b)(4)+ no188z).Involved componet: nl473 -univation f meniscal comp.T4 rm/lm 7mm - 52047925.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T4 LM
• Type of Device: KNEE ENDOPROSTHESES
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11856559
• MDR Text Key: 261775804
• Report Number: 9610612-2021-00436
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046964053764
• UDI-Public: 4046964053764
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/20/2021

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 Expiration Date: 01/06/2024
• Device Model Number: NO165Z
• Device Catalogue Number: NO165Z
• Device Lot Number: 52048027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2014
• 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