MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number	02.124.412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Date of non-union is unknown.Additional procodes: hrs, hwc.Lot number is unknown.Complainant parts are not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 on (b)(6) 2017, the patient underwent revision surgery to remove the variable angle (va) locking compression plate (lcp) distal femur plate and unknown screw from the patient¿s distal femur due to non-union.The hardware was originally implanted on (b)(6) 2017.The patient was revised to a 4.5mm lcp condylar plate and unknown screws.On (b)(6) 2018, the patient underwent a second revision procedure to remove the 4.5mm lcp condylar plate and unknown screws from the patient¿s distal femur due to non-union.The patient was revised to a prosthetic distal femur.Patient consequence is unknown.This report is for a 4.5mm va-lcp curved condylar plate/12 hole/266mm/right.This is report 1 of 2 for (b)(4).This report will address the va lcp distal femur plate and unknown screws removed on (b)(6) 2017.The revision surgery on (b)(6) 2018 has been captured under complaint number (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/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: 7793376
• Report Number: 2939274-2018-53355
• Device Sequence Number: 1195544
• Product Code: JDP
• UDI-Device Identifier: 10886982042859
• UDI-Public: (01)10886982042859
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 02.124.412
• Device Catalogue Number: 02.124.412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR