MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT; PLATE,FIXATION,BONE

Model Number	02.124.410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Additional device product codes: jds, hwc complainant device is not expected to be returned for manufacturer review/investigation.Patient¿s code (b)(4) is used to capture the required medical/surgical intervention to preclude permanent damage to a body a device history record (dhr) review was performed for part # 02.124.410, lot # 8788833: manufacturing location: (b)(4), release to warehouse date: 07.Jan.2014: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 that a one (1) plate and twelve (12) screws were removed from a patient¿s femur and she underwent a total knee replacement on (b)(6) 2017.The initial surgery was conducted on (b)(6) 2016 to treat a right distal femur fracture and one (1) plate and twelve (12) screws construct was implanted in the patient.As per the surgeon, the patient had a very badly broken distal femur initially and had developed post-traumatic arthritis due to the same, thus needing a total knee replacement.The plate and all screws were removed intact.The procedure of removal of initial implant construct and total knee replacement was conducted successfully without any complications and there was no reported surgical delay.This report is for one (1) 4.5mm va-lcp curved condylar plate this is report 1 of 13 for complaint (b)(4).
Additional Manufacturer Narrative
Additional device product codes: jdp, hwc.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/10 HOLE/230MM/RIGHT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7050407
• Report Number: 8030965-2017-50066
• Device Sequence Number: 1156311
• Product Code: HRS
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811(10)8788833
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2017

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: 02.124.410
• Device Catalogue Number: 02.124.410
• Device Lot Number: 8788833
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/28/2017
• 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: 36 YR
• Patient Weight: 71