MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.411

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2014

Event Type  Injury  

Event Description

It was reported that on follow up x-rays, a locking condylar plate broke and was replaced with a retrograde femoral nail.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: hrs and hwc.The lot number provided could not be verified; therefore, without a lot number the device history record review and the investigation could not be completed; dhr 02.124.411 - 4.5mm va-lcp curved condylar - lot 8788772 - comact-092113 there is no dhr information in docusphere for this lot.The lot number exists in (b)(4) associated with (b)(4) issued january 10, 2014 by synthes (b)(4).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: date of revision/explant procedure is unknown.Device history review: manufacturing location: (b)(4) - manufacturing date: january 7, 2014 - 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.Event date: unknown.Device 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.

Manufacturer 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/10 HOLE/230MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA 19380 CH6; SZ 19380 CH68
• 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: 4230110
• MDR Text Key: 5071586
• Report Number: 2520274-2014-14550
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.411
• Device Lot Number: 8788772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 146