MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F4 RM; FEMUR IMPLANTS UNIVATION

Model Number NO183Z

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: post-operative medical intervention was necessary, revision surgery was performed.The device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to the specification valid at the time of production.No similar incidents have been filed with products from these batches.Based on the information available it is possible to determine a conclusion and root cause for the mentioned failure.It is assumed that the failure is not product related.It could be possible that the mentioned failure s usage related.A capa was created.

Event Description

It was reported by the healthcare professional to the company sales representative "femur loosened and was revised." no patient injury was reported.No delay in surgery was reported.Components in use listed as concomitant devices are: no159z, as univation xf tibia cemented t4 rm, batch # 51979981; nl479, univation f meniscal comp.T4 rm/lm 8mm, batch #51974138.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 RM
• Type of Device: FEMUR IMPLANTS UNIVATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7916627
• MDR Text Key: 121990634
• Report Number: 9610612-2018-00425
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: NO183Z
• Device Catalogue Number: NO183Z
• Device Lot Number: 52030907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/10/2018
• Device Age: 4 YR
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention