MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS AS ENDURO FEMORAL COMPONENT CEMENTED F2R; KNEE ENDOPROSTHETICS

Model Number NB018Z

Device Problem Metal Shedding Debris (1804)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).It was reported that after a patient underwent an implantation of an enduro as prosthesis, metallosis occurred.This was confirmed by a pathological report.Components in use listed as concomitant devices are: (b)(4) / as enduro femoral component cemented f2r; (b)(4) / as femur etens.6 d18x77; (b)(4) / as tibia offset stem d18x52mm cemented; (b)(4) / as enduro tibial comp.Offset cemented t3.

Manufacturer Narrative

Investigation: due to the fact that the prosthesis is still in-situ, an investigation could not be performed.Batch history review: 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 our specifications 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 and as a result of our investigation, a product related failure can be excluded.The failure is most probably user or patient related.No capa is necessary.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F2R
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 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: 6225237
• MDR Text Key: 64254234
• Report Number: 9610612-2017-00001
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: NB018Z
• Device Catalogue Number: NB018Z
• Device Lot Number: 52133374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/20/2016
• Device Age: 20 MO
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2015
• 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: (B)(4) / AS ENDURO TIBIAL COMP. OFFSET CEMENTED T3; (B)(4) / AS FEMUR ETENS. 6 D18X77; (B)(4) / AS TIBIA OFFSET STEM D18X52MM CEMENTED
• Patient Outcome(s): Other