MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.407

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional product codes: hrs and hwc.Therapy date: exact date unknown; reported as approximately 1 year prior to explant on (b)(6) 2016.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: may 15, 2013.No non-conformance reports 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.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

It is reported patient was implanted with the 4.5mm variable angle (va) locking compression plate (lcp) curved condylar plate and eleven (11) screws for a fracture of the left distal femur approximately one year prior to removal.Patient presented to explant surgeon approximately two (2) weeks prior to removal with discomfort.X-rays taken on unknown date revealed the plate was broken.Patient was returned to surgery on november 15, 2016 where surgeon removed all hardware and revised patient to a new 4.5mm va lcp condylar plate and screws.Surgery was completed successfully with no delay and no harm to patient.Concomitant medical products: 5.0mm cannulated va locking screw 65mm (part number 02.231.665, lot number unknown, quantity 1), 5.0mm cannulated va locking screw 85mm (part number 02.231.685, lot number unknown, quantity 1), 5.0mm cannulated va locking screw 80mm (part number 02.231.680, lot number unknown, quantity 3), 5.0mm va locking screw 44mm (part number 02.231.244, lot number unknown, quantity 1), 5.0mm va locking screw 40mm (part number 02.231.240, lot number unknown, quantity 1), 5.0mm va locking screw 65mm (part number 02.231.265, lot number unknown, quantity 1), 5mm cannulated conical screw 75mm (part number 02.205.275, lot number unknown, quantity 1), 4.5mm cortex screw self tapping 40mm (part number 214.840, lot number unknown, quantity 1), 4.5mm cortex screw self tapping 44mm (part number 214.844, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/LEFT
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6154559
• MDR Text Key: 61729834
• Report Number: 1000562954-2016-10225
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.407
• Device Lot Number: 8429119
• Other Device ID Number: (01)10886982042750(10)8429119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 PART 02.205.275, LOT UNKNOWN, SCREW; 1 PART 02.231.240, LOT UNKNOWN, SCREW; 1 PART 02.231.244, LOT UNKNOWN, SCREW; 1 PART 02.231.265, LOT UNKNOWN, SCREW; 1 PART 02.231.665, LOT UNKNOWN, SCREW; 1 PART 02.231.685, LOT UNKNOWN, SCREW; 1 PART 214.840, LOT UNKNOWN, SCREW; 1 PART 214.844, LOT UNKNOWN, SCREW; 3 PART 02.231.680, LOT UNKNOWN, SCREW
• Patient Outcome(s): Required Intervention
• Patient Weight: 95