MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.418

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The adverse event date for the patient¿s infection that occurred post operatively is unknown.Additional product codes: hrs, hwc.Lot number provided 9174737 was not valid, most likely correct lot number is 9174739.This is found in the completed product investigation's dhr.Manufacturing site: (b)(4).Release to warehouse date: october 06, 2014.No non-conformance reports (ncrs) 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 product investigation is in the complete phase so the information in it is ready to report.In this case it is only the dhr information as the product was not returned so a full investigation was not completed.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

It was reported that the patient underwent removal of intact hardware from the femur on (b)(6) 2018 due to an infection.The bipolar hip (non-synthes), one (1) variable angle locking compression plate (va-lcp) curved condylar plate, three (3) 5mm periprosthetic locking screws, one (1) 5mm locking screw, three (3) 4.5mm cortex screws, and six (6) 5mm cannulated locking screws were originally implanted on an unknown date.The patient underwent an incision and drainage (i&d) procedure and an antibiotic cement spacer was inserted.The surgery was successfully completed with no delay.The patient outcome was reported as ok.Concomitant devices reported: bipolar hip (part # unknown, lot # unknown, quantity # unknown) this complaint involves fourteen (14) devices.This is report 1 of 5 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7459079
• MDR Text Key: 106469303
• Report Number: 2939274-2018-51895
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Device Lot Number: 9174739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Date Device Manufactured: 10/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 71