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

Catalog Number 02.124.418S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: a manufacturing investigation was conducted.The report indicates that the plate 02.124.418s was implanted on (b)(6) 2014 for the fixation of a periprosthetic femur fracture on the right side.According to the device report the bending i incipient cracking of the plate was observed on (b)(6) 2014.The revision surgery was conducted the same day with the removal of the implants and re-osteosynthesis by means of a plate from a different source.Based on the topography of the fracture surfaces, it can be concluded that the plate was subjected to low dynamic bending loads (one sided).Constantly alternating bending loads i load cycles (during walking) led to the fatigue of the material, then to multiple cracks at various positions and finally to the overload respectively to the fatigue fracture of the plate.The plate could not resist the applied force which finally led to the material overload i fatigue failure.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 (b)(4) reports an event in (b)(6) as follows: it was reported that a patient had periprosthetic fracture initial operation on (b)(6) 2014.It was notes that the query plate bent 10/52 post on (b)(6) 2014.There was also a plate revised on (b)(6) 2014.Query plate failed prior to this date.All screw heads were intact, plate bent and cracked but still one piece.A open reduction internal fixation a competitor plate and cables was performed.There no reports of a surgical delay.This report is for 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code for this report includes; hrs, hwc.The investigation could not be completed; no conclusion could be drawn, as product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.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/RT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• 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: 4297589
• MDR Text Key: 13107149
• Report Number: 1000562954-2014-10214
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 02.124.418S
• Device Lot Number: 8043229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR