MAUDE Adverse Event Report: SYNTHES USA; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Device Problem Unintended Movement (3026)

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 that a distal femoral fracture became displaced when three (3) variable angle locking screws backed out of a variable angle condylar plate.The initial distal femoral stem prostheses procedure for a peri-prosthetic distal femur fracture took place on (b)(6) 2015.It was reported that the patient, who was described as ¿very obese,¿ mobilized early postoperative.An x-ray taken on (b)(6) 2015 confirmed the displaced fracture and showed the backed-out screws.A revision procedure to the knee stem occurred on (b)(6) 2015.This report is for two (2) unknown locking screws.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Patient¿s date of birth and weight are unknown.Event date: unknown.This report is for two (2) unknown locking screws.They have one of the following part numbers: 02.231.270, 02.231.260, or 02.231.250.Additional product codes for this report include hrs and hwc.Complainant part is unavailable for return; it has been disposed of by the facility.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4590427
• MDR Text Key: 5340226
• Report Number: 2520274-2015-11693
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 02/27/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention