MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/18HOLE/370MM/LT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.419S

Device Problem Bent (1059)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient identifier and age or date of birth not available for reporting.Additional product codes: hrs, hwc.(b)(4) lot number unknown.Date of implant is approximately (b)(6), exact date is unknown.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date is approximately (b)(6), exact date is unknown.(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.Device was used for treatment, not diagnosis.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) as follows: it was reported patient underwent an open reduction internal fixation (orif) of the distal femur on unknown date.X-rays taken during the three (3) month post-operative visit revealed the variable angle locking compression plate (va-lcp) curved condylar plate is beginning to bend.A varus deformity in the distal femur is also noted.No revision surgery is planned at this time.Surgeon will follow patient to exclude infection and will recheck further deformation before determining if a revision with additional intramedullary nail or medial plate support.Concomitant devices reported: screw (quantity 1).This report is for one (1) 4.5 mm va-lcp curved condylar plate.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Based on the available information (x-rays and pictures) we were able to confirm that we see bent/deformed plate.Root cause could not be defined due the material not returned.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/18HOLE/370MM/LT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6821012
• MDR Text Key: 83659991
• Report Number: 1000562954-2017-10213
• 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: 08/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.419S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• 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
• Treatment: SCREW (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Weight: 85