MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS AS UNIVATION XF FEMUR CEMENTED F4 LM; FEMUR IMPLANTS UNIVATION

Model Number NO188Z

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Revision due to low-grade-infect.Implant could be explanted with 2 to 3 punches.Hardly cement compound.All med watch submissions related to this report are: 9610612-2018-00025, 9610612-2018-00026.Components in use listed as concomitant devices are: no188z / as univation xf femur cemented f4 lm, no166z / as univation xf tibia cemented t, nl480 / univation f meniscal comp.T5 rm.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.No abnormalities or damages were found on the coated surface of the implant.On the femur, as well as on the tibia component, some bone cement residues could be found.Batch history review: the device quality and manufacturing history records have been checked and found to be according to our specification, valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available as well as a result of our investigation we assume that the root cause of this failure is not product related.Rational: it could be possible that there were problems with the cement technique.Potential sources of faults relating to the cement.The processing time of the used cement was exceeded.Incorrect temperature.Unfavorable storage.The age of the cement.Incorrect handling of the cement.No capa is necessary.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 LM
• Type of Device: FEMUR IMPLANTS UNIVATION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7232634
• MDR Text Key: 98744900
• Report Number: 9610612-2018-00025
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 52319862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Distributor Facility Aware Date: 01/12/2018
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL480 /UNIVATION F MENISCAL COMP T5 RM; NO188Z / AS UNIVATION XF FEMUR CEMENTED
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR