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

Model Number NO188Z

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Post Operative Wound Infection (2446)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

If additional information / investigation results become available, it will be provided in a supplemental report.

Event 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 Description

No updates.

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 Description

Update: involved components - no165z - 52048027 univation tibial component nl473 - 52047925 univation meniscal component.

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
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11712113
• MDR Text Key: 252010809
• Report Number: 2916714-2021-00062
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046964053658
• UDI-Public: 4046964053658
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021,05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 04/22/2021
• Distributor Facility Aware Date: 03/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL473 - 52047925; NL473 - 52047925; NO165Z - 52048027; NO165Z - 52048027
• Patient Outcome(s): Required Intervention