MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM PROX FEMUR LCK PLATE 6H L 180MM; PLATE, FIXATION, BONE

Catalog Number 74800406

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that post locking proximal femoral plate operation the fell during showering, then felt a pain on left hip.During post-surgery check, a breakage of internal fixation after left hip traumatic coxa vara operation was found.On (b)(6) 2016, the patient accepted intramedullary nail internal fixation.

• Brand Name: 4.5MM PROX FEMUR LCK PLATE 6H L 180MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: clauda odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6134155
• MDR Text Key: 61084182
• Report Number: 1020279-2016-00920
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74800406
• Device Lot Number: 15JT58997
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR