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

Model Number	NO188Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information / investigation results become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with an as univation xf femur.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).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Investigation: reference code: (b)(4).Device name as univation xf femur cemented f4lm.Serial number: n/a batch number: 52048039.Manufacturing date 2014-07-15.Reference code: (b)(4).Device name as univation xf tibia cemented t4lm.Serial number: n/a.Batch number: 52048027.Manufacturing date: 2014-07-25.Device name: nl473 univation f meniscal comp.T4 rm/lm 7mm.Failure description: no product at hand.Therefore a failure description is not possible.Investigation: no product at hand.Therefore an investigation is not possible.Pictorial documentation: there are no pictures available.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) 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.Explanation and conclusion: there are no hints for a material problem.According to the quality standard and dhr files a material defect and production error was not found.In the light of the small amount of information received and without the product for investigation, a clear conclusion cannot be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Furthermore, no clear error pattern can be identified on the basis of the description, which makes a conclusion and root cause analysis impossible.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa request necessary.
Event or Problem Description
Update: involved components - no165z - 52048027 univation tibial component nl473 - 52047925 univation meniscal component.
Additional Manufacturer Narrative
Updates: b5 - associated components d6 - lot number and expiration date d10 - associated components f9 - age of device.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 LM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11712113
• Report Number: 2916714-2021-00062
• Device Sequence Number: 19940280
• Product Code: HRY
• UDI-Device Identifier: 04046964053658
• UDI-Public: 4046964053658
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2021
• Report Date (Section F): 04/22/2021

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: 06/01/2024
• Device Model Number: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 52048039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/07/2021; 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NL473 - 52047925; NL473 - 52047925; NO165Z - 52048027; NO165Z - 52048027
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 04/22/2021