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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7459079
• Report Number: 2939274-2018-51895
• Device Sequence Number: 16478794
• Product Code: JDP
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Device Lot Number: 9174739
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 71