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

Model Number	NO165Z
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11856559
• Report Number: 9610612-2021-00436
• Device Sequence Number: 4016735
• Product Code: HRY
• UDI-Device Identifier: 04046964053764
• UDI-Public: 4046964053764
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K131167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention