MAUDE Adverse Event Report: SYNTHES (USA) 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.414

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient¿s initials are unavailable.Date of event is unknown.Additional product codes: hrs, hwc.Device will not be returned.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) is as follows; it was reported that the patient underwent a distal femoral replacement arthroplasty revision on (b)(6) 2016 to remove the broken distal end of the of a 4.5mm (14-hole) va-lcp curved condylar plate.The remaining unbroken part of the plate was cut with a metal cutting burr, along with the distal femur.The surgeon chose to treat the patient with a non-synthes long-stemmed distal femoral replacement and left the proximal part of the plate in situ to neutralize the stress riser at the tip of the distal femoral stem.The proximal end is still in the patient and the distal end where the plate failed has been burred away.The patient was mobilizing short distances with a frame following the primary surgery following the initial fracture fixation.The patient initially underwent an open reduction internal fixation for periprosthetic distal femur fracture.Patient sustained a comminuted distal metaphyseal fracture proximal to a total knee replacement.This fracture was treated with open reduction internal fixation using the va-lcp curved condylar plating system on (b)(6) 2016.The patient visited the emergency department on (b)(6) 2016.Plain films revealed a deformed implant appearing to have undergone fatigue failure and varus malalignment of the distal femur fracture.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5932120
• MDR Text Key: 54040498
• Report Number: 2520274-2016-14447
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 103