MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS AS UNIVATION XF FEMUR CEMENTED F2 RM; FEMUR IMPLANTS UNIVATION

Model Number NO181Z

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the available devices are in decontaminated condition for investigation.Complete loosening of the femur component, no connection between bone cement and prosthesis.Post-operative medical intervention was necessary, revision surgery.The available explants are in an undamaged condition and show no abnormalities or deviations.The components have been examined visually and microscopically with the digital microscope and camera.No abnormalities or damages were found on the coated surface of the implants.Furthermore the surface roughness of the as coated surface was measured in the precision measurement room with the result, that surface roughness complying with the specification.The devices 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 our specification valid at the time of production.No similar incidents have been file with products from these batches.Based on the information available as well as a result of the investigation the root cause of this failure is not product related.A capa is not necessary.

Event Description

Country of complaint: (b)(6).Early loosening, because there is no connection between femoral component and cement.Components in use listed as concomitants devices are: no181z / as univation xf femur cemented f2 rm.No159z / as univation xf tibia cemented t4 rm.Nl473 / univation f meniscal comp.T4 rm/lm 7mm.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F2 RM
• Type of Device: FEMUR IMPLANTS UNIVATION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7313373
• MDR Text Key: 101509351
• Report Number: 9610612-2018-00061
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

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: NO181Z
• Device Catalogue Number: NO181Z
• Device Lot Number: 52213824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Distributor Facility Aware Date: 02/06/2018
• Device Age: 2 YR
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• 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
• Treatment: NL473 / UNIVATION F MENISCAL COMP.T4 RM/LM 7MM; NO159Z / AS UNIVATION XF TIBIA CEMENTED T4 RM; NO181Z / AS UNIVATION XF FEMUR CEMENTED F2 RM
• Patient Outcome(s): Other
• Patient Age: 58 YR