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

Catalog Number 02.124.419

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the patient was implanted with a competitor's femoral plate and allograft strut, for a vancouver c fracture and required a revision due to the competitor's plate fractured at the non- union site.The plate was reported to have been removed for the non-union with no issues and the plate was reported to be intact.The patient was revised to a synthes variable angle condylar plate, cables and allograft strut.The surgeon implanted on a long plate which overlapped the stem and used screws aimed anterior to the stem and cables.An allograft strut was placed on the anterior aspect of the femur and cable.It was reported through x-ray the synthes plate broke at the same location of the non-union site after the patient was instructed to apply weight as tolerated.The patient was reported to have heard a crack on (b)(6) 2014 which could have been when the plate breakage occurred.It was further reported the patient is quite small and light weighted leading the surgeon to expect the plate to support her partial weight bearing.The revision surgery was delayed as the patient was reported to be febrile.An update was provided on (b)(6) 2014 that the plate and screws have been removed and will be returned for further investigation this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional common device names: hrs, hwc.(b)(6).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: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As per received condition of device; it plate is broken.Based on the topography of the fracture surface, it is notes that the implant was subjected to moderate dynamic bending loads (one sided).Constant load cycles during walking led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the variable angle locking compression plate (va-lcp).Because of the non-union the plate had to act as a single stabilizer.The variable angle locking compression plate (va-lcp) could not resist the applied force which finally led to the material overload / fatigue failure.Postoperative activities of the patient caused instability of the fracture as well.A failure resulting from either a material defect or the manufacturing process can be excluded.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/18 HOLE/370MM/LEFT
• 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: 3929626
• MDR Text Key: 4532856
• Report Number: 1000562954-2014-10118
• 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,Followup
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.419
• Device Lot Number: 8110618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/07/2014; 10/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50