MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F4 LM; KNEE ENDOPROSTHESES

Model Number NO188Z

Device Problem Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Post Operative Wound Infection (2446)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with no188z - as univation xf femur cemented f4 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 aag reference (b)(4).

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.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 LM
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11711665
• MDR Text Key: 253606736
• Report Number: 9610612-2021-00332
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046964053658
• UDI-Public: 4046964053658
• 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: 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: 06/01/2024
• Device Model Number: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 52048039
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL473 - 52047925
• Patient Outcome(s): Required Intervention