MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT,FIXATION DEVICE

Catalog Number 02.124.412

Device Problem Fracture (1260)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that the surgeon performed a hardware revision due to a variable angle locking compression plate-condylar plate (va lcp) breakage on two areas.The original implant procedure was performed on (b)(6) 2014 to treat a femur fracture.Postoperatively, it was discovered that the patient had delayed healing and a fractured condylar plate.On (b)(6) 2014 the surgeon removed the fractured condylar plate and replaced it with another va lcp condylar plate of the same type, 2 cables around the plate and femur, and he applied antibiotic cement to the non-union fracture.The surgeon also implanted a 3.5mm lcp 12 hole plate with cortex screws on the shaft and locking screws on the distal end.The procedure was completed successfully without delay.There was no reported patient harm.A review of the 3 x-rays supplied was completed by the medical director with the following analysis: the first, described as pre-op, which shows a highly comminuted distal? right femur fracture, proximal to a tka and distal to a proximal intramedullary implant.The fracture was treated with a va-lcp condylar plate on the ?lateral side with 3 distal screws inserted close to the tka implant and a further screw along with a cerclage wire inserted proximal to the fracture line.The description of the complaint states that there is a va-lcp condylar plate broken in 2 areas.The breaks are quite subtle but it does appear to be broken distally and again just proximal to the tka implant.The two postoperative xrays are fluoroscopic views and show that the original va-lcp plate was removed and replaced with a similar plate along with another plate on the medial side.Total knee arthroscopy (tka).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

No nonconformance reports were generated during production.Review of the device history record 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: 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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
• Type of Device: IMPLANT,FIXATION DEVICE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3777306
• MDR Text Key: 4434242
• Report Number: 1000562954-2014-10059
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.412
• Device Lot Number: 8279766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention