MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS AS ENDURO FEMORAL COMPONENT CEMENTED F2L; FEMUR IMPLANTS ENDURO

Model Number NB015Z

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the device is not available for investigation.Due to a sagittal instability with pronounced genu recurvatum, an implant exchange was performed in 2015.A knee endoprosthesis was implanted.Post-operative medical intervention was necessary, revision operation.Due to the circumstances that a devices was not received for investigation, an investigation is not possible.An x-ray image show no clearly visible implant failure.There is no information how significant the metal debris in the patient exist.The driver 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 oem specification.No similar incidents have been filed with products from these batches.Due to the circumstance that a device was to received for investigation a conclusion can not be determined of the root cause of failure.Also regard to the loosening between the femoral component and the cement stem a possible root cause for this failure could be an insufficient tightening of the femoral stem.

Event Description

Country of complaint: (b)(6).A knee prosthesis was performed due to a sagittal instability with pronounced genu recurvatum in 2015.A coupled knee endoprosthesis of the aesculap type enduro was implanted.A new revision surgery was carried out on (b)(6) 2017 due to a new knee joint symptom with detected metallosis.There was a loosening between the femoral component and the cemented stem extension.Thus, with firm cemented extension, the femoral component was loosened on the condyle surface.An exchange surgery took place on (b)(6) 2015 and the complained product was implanted.Persistant symptoms of synovitis are mentioned.Checkup of synovitis and genu recurvatum was done.During a "staging ask" the diagnosis of metallosis was identified on (b)(6) 2017.An open revision surgery with planned synovectomy and changing the inlay was on (b)(6) 2017.Intraoperative the completely loosening of the femoral surface component(nb015z) with the connection of femoral stem component was located.The femoral stemp (nr293z) was firmly cemented with the femur.That was the reason why the intensity of loosening could not be pointed out by x-ray.The prosthesis was removed completely.The explant was given to the patient.Components in use listed as concomitant devices are: nb015z / as enduro femoral component cemented f2l.Nr293z / as femur extens.Stem 6° d18x77 cemented.Nr591z / as enduro fem.Spacer post/dist f2 8x12mm.Nr591z / as enduro fem.Spacer post/dist f2 8x12mm.Nb011z / as enduro tibial comp.Offset cemented t1.Nr193z / as tibia offset stem d18x52mm cemented.Nb036z / as enduro tibia hemi-wedge t1 8mm rl/lm.Nb026z / as enduro tibia hemi-wedge t1 8mm rm/ll.Nr400z / as nut f/femur extens.Stem all sz.Neutr.Nr882z / as enduro meniscal component f2 14mm.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F2L
• Type of Device: FEMUR IMPLANTS ENDURO
• 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: 7001163
• MDR Text Key: 92045913
• Report Number: 9610612-2017-00541
• 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
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: NB015Z
• Device Catalogue Number: NB015Z
• Device Lot Number: 52160084
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/25/2017
• Device Age: 2 YR
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR