MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; PLATE, FIXATION, BONE

Model Number 02.124.415

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient weight not provided for reporting.Additional product code: hwc.Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.The plate broke postoperatively requiring revision surgery.Device history records review was conducted.The report indicates that the: part #02.124.415, lot #9662210, manufacturing location: (b)(4), manufacturing date: 30.Sep.2015.Product was not returned.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned; the device history records revealed that no ncrs were generated during production and no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent revision surgery on (b)(6) 2017 due to a failed 4.5 variable angle (va) condylar plate and nonunion/delayed union of the fracture.The original implant date was in (b)(6) 2017 due to a periprosthetic fracture around a total hip arthroplasty (tha) and total knee arthroplasty (tka).The surgeon stated there was callous healing; however, the implant eventually failed and broke in the shaft of the plate.The surgeon thought the implant failure was due to being too stiff or rigid.One broken plate, 8 screws and 2 cables were removed intact.The patient was revised to another plate.The surgery was successfully completed with no surgical delay.This complaint involves one device.Concomitant devices reported: screw (part # unknown, lot # unknown, quantity 8), 1.7mm 5.5 cable (part # unknown, lot # unknown, quantity 2).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Updated concomitant devices.Therapy date is reported as (b)(6) 2017, exact date is unknown.Corrected data: date of postoperative plate breakage and non-union development is unknown.Original implant date is reported as (b)(6) 2017, exact date is unknown.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

Concomitant devices reported: 5.0 variable angle cannulated screw (part # unknown, lot # unknown, quantity 3), 5.0 variable angle locking screw (part # unknown, lot # unknown, quantity 2), 4.5 cortex screw (part # unknown, lot # unknown, quantity 1), variable angle periprosthetic locking screw (part # unknown, lot # unknown, quantity 2), 1.7mm 5.5 cable (part # unknown, lot # unknown, quantity 2).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT
• Type of Device: PLATE, FIXATION, BONE
• 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: 6718415
• MDR Text Key: 80193948
• Report Number: 1000562954-2017-10133
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Public: (01)10886982042910910)9662210
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.415
• Device Catalogue Number: 02.124.415
• Device Lot Number: 9662210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1.7MM 5.5 CABLE PART # UNKNOWN, LOT # UNK, QTY 10; SCREW PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 8
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR