MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F3 RM; FEMUR IMPLANTS UNIVATION

Model Number NO182Z

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: ongoing.If additional information is received a follow up report will be submitted.

Event Description

It was reported that coating rubbed off device intraoperatively.During a uni- x knee replacement procedure it was reported the surgeon removed the implant from the box and inspected it prior to use.The surgeon felt there were areas on the under surface post that looked like coating was rubbed off.The device was not used.It was reported that two devices were available and the procedure was completed successfully.The patient outcome was acceptable.The incident did result in a 5-10 minute delay in surgery.

Manufacturer Narrative

Aesculap inc.(importer, registration no.(b)(4)) is submitting this report on behalf of aesculap ag (manufacturer, registration no.(b)(4)).Exemption number: (b)(4).No product at hand, therefore an investigation was not possible.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to specification valid during the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available it is not possible to determine a possible root cause for the failure.At this time, we assume that the failure is not product related.Rationale: in the light of the little information received and due to the circumstance that we did not receive the complaint device it is not possible to determine a root cause for the mentioned failure.There are no indications for a material problem.According to the quality standard and dhr files a material defect and production error is unlikely.No capa necessary.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F3 RM
• Type of Device: FEMUR IMPLANTS UNIVATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8358721
• MDR Text Key: 136787925
• Report Number: 9610612-2019-00101
• Device Sequence Number: 1
• Product Code: HRY
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO182Z
• Device Catalogue Number: NO182Z
• Device Lot Number: 52310670
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/17/2019
• Device Age: 22 MO
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1