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

Model Number NO188Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/17/2020

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 revision due to loosening.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00877 (b)(4).Involved components.Nl472 - univation f meniscal comp.T3 rm/lm 7mm -52476980.

Manufacturer Narrative

Investigation: the investigator examined the product visually and microscopically.The available explants are in an undamaged condition and show no abnormalities or deviations.In the delivered condition, there are almost no bone cement residues visible on the implants.The coated surface of both implants shows little visible signs of abrasion.The origin of this traces are unknown.The coated surface show no failure or deviation.The visible discoloration of both surfaces is a result of oxidation and does not affect the material properties in any way.There are no x- ray figures provided.The gliding surface of the meniscal component shows several little imprints and scratches which probably resulting from third body wear (bone chips and/or bone cement residues).Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are 2 similar complaints against the same lot number: 52370286 (all registered as leading component).Explanation and rationale: on the basis of the current information, a clear conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.A product safety case was initiated.

• 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: 10977877
• MDR Text Key: 220502424
• Report Number: 9610612-2020-00876
• 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: 02/05/2021

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 Model Number: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 52370286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2020
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 02/14/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL472 - 52476980; NL472 - 52476980
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR