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

Catalog Number 02.124.419S

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: the subject device was explanted but the exact date of explant is unknown.Explant/revision surgery reportedly was performed approximately 12 weeks after the unknown implant date in july 2014.A manufacturing investigation was performed for the subject device (va-lcp condylar plate, part 02.124.419s).The manufacturing investigation included the inspection of the subject device dimensions, examination of the fracture surfaces by scanning electron microscopy (sem), and review of the manufacturing documents, technical drawings and the raw-material inspections sheets.The subject device was made of material (b)(4) (stainless steel).The examination of the raw-material inspection sheet from the supplier and the manufacturing documents of the producer showed no deviation in relation to chemical composition, microstructure and mechanical properties.The dimensions of the subject device were checked using a digital sliding caliper and were found to be in compliance with the technical drawings.The macroscopic examination revealed corrosion and mechanical damage from the locking attachment plates, observed at the proximal end of the subject device.The sem evaluation concluded that the subject device failure was caused by fatigue and overload.In conclusion, based on the topography of the fracture surfaces, it can be concluded that the subject device was subjected to low dynamic bending loads (one sided).Constantly alternating bending loads / 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 va-lcp condylar plate (subject device).The subject device could not resist the applied force which finally led to the material overload i fatigue failure.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported, a va-condylar plate broke 12 weeks after implantation.This is 1 of 1 report for (b)(4).

Manufacturer Narrative

Device used for treatment not diagnosis.Implant, (b)(6) 2014, exact date is unknown.The part was received; an evaluation is currently in progress.A review of the device history record did not reveal conditions that could have contributed to the reported event.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/LT-STER
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• 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: 4339919
• MDR Text Key: 13395500
• Report Number: 1000562954-2014-10224
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 02.124.419S
• Device Lot Number: 8955384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR