MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: (b)(6).Date patient pain began is not known.(b)(4).Date of implant reported as 2016, exact date is not known.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent a partial revision of total knee and knee manipulation, and was implanted with a 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate, four (4) 4.5mm cortex screws, three (3) cannulated va locking screws, and two (2) 5.0mm cannulated va locking screws on unknown date in 2016.On unknown date patient reported pain and stiffness associated with the implants.Patient was returned to surgery on (b)(6) 2018 where all hardware was removed.Patient was not revised to any additional hardware as the fracture had healed.Surgery was completed successfully.Patient reported in stable condition.This report is for one (1) 4.5mm va-lcp curved condylar plate.(b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 02.124.406, lot# 9265132.Manufacturing location: (b)(4), release to warehouse date: dec 01, 2014.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/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: 7328012
• Report Number: 2939274-2018-50977
• Device Sequence Number: 16513158
• Product Code: JDP
• UDI-Device Identifier: 10886982042736
• UDI-Public: (01)10886982042736(10)9265132
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 02.124.406
• Device Catalogue Number: 02.124.406
• Device Lot Number: 9265132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/23/2018
• 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: 52 YR
• Patient Weight: 91